Abbott Recalls FreeStyle InsuLinx Blood Glucose Meters

On April 15, Abbott announced a voluntary recall of their FreeStyle InsuLinx blood glucose meters. The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL. No other Abbott blood glucose meters are affected by the issue. 

Customers who have purchased the meters can take one of the two following steps: 

1. Log on to www.freestyleinsulinx.com/swupdate to access a software update. 
2. Contact Abbott Diabetes Care Customer Service at 866-723-2697 to arrange for return and replacement of their meter at no charge. 

To learn more, click here. 

St. Jude Medical Recalls Heart Implant Tool

St. Jude Medical has recalled the AMPLATZER TorqVue FX Delivery System, a tool that is used to to help mend a type of heart defect that causes holes in the upper chambers of the heart. The FDA is classifying the action as a Class I recall, meaning that patients treated with the devices could be seriously injured or killed.

The recall comes after a small number of incidents in which the delivery system's wire fractured during surgery. The recalled devices were manufactured between August 24 and September 24 of 2012.

To learn more, click here.

Generic Lipitor Recalled Over Glass Particles

Ranbaxy Pharmaceuticals Inc. has recalled more than 40 batches of its generic version of Lipitor after warning that the medication might contain small particles of glass.

The recall applies to to bottles of 10-, 20- and 40-milligram tablets of atorvastatin calcium, the generic version of Lipitor. According to a statement from Ranbaxy, "The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles less than 1 mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind."

To view a full list of the recalled lots, click here.

To learn more, click here.

FDA Encourages Healthcare Providers to Contact Patients Who Received Injectables from NECC in Wake of Fungal Meningitis Outbreak

The FDA is recommending that medical professionals reach out to any patient who was administered an injectable product distributed by the New England Compound Center (NECC). This comes on the heels of a fungal meningitis outbreak being tied to steroids distributed by the NECC.

At this point, the fungal meningitis has been traced to injections of  methylprednisolone acetate as well as triamcinolone acetonide. NECC has issued a recall of all of its products (to view the list of affected products, click here).

Since the outbreak began, the FDA has has been conducting an ongoing investigation into contamination at  NECC, which is located in Framingham, Massachusetts. As a result of this investigation, they have recommended that healthcare professionals retain NECC products, secure them and withhold them from use. They are also advising them to follow up with any patient who received an injectable drug from NECC and asking them to be on the lookout for symptoms of possible infection, including fever, swelling, increasing pain, redness, warmth at the injection site, chest pain, drainage from the surgical site, visual changes and redness or discharge from the eyes. If patients notice any of these symptoms, they should contact a healthcare provider immediately.

At this time, the FDA is not urging patient follow-up for those who received non-injected NECC drugs, such as lotions, creams, suppositories and eye drops not used in conjunction with surgery.

To learn more and stay up to date on any new developments, click here.

PDI Issues Wipe Recall

Professional Disposables International Inc. (PDI) has issued a voluntary recall of non-sterile alcohol prep pads because of potential bacterial contamination.  
The recall was announced after the FDA visited the company's manufacturing plant and tests showed the presence of bacillus cereus on the pads. Bacillus cereus is the same bacteria that triggered prep pad recalls, a plant shutdown and lawsuits against the Triad Group and H&P Industries. However, PDI stressed that the levels of bacteria that were detected were low enough that the products remained within allowed specifications and that the recall was being done out of an abundance of caution.

To learn more about the voluntary recall and view the affected lot numbers, click here.

More Than 60,000 Bottles of Extra-Strength Tylenol Recalled

McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, is voluntarily recalling 60,912 bottles of extra-strength Tylenol caplets after consumers reported detecting a musty, moldy odor.

Although serious adverse reactions are unlikely, it is possible that people who come in contact with the odor (which has been linked to traces of the chemical tribromoanisole,or TBA) could experience temporary gastrointestinal symptoms.

The recalled products are from lot number ABA619 and have the UPC code 300450444271. These numbers can be found on the side of the bottle label. Consumers who have this product in their possession should stop using it and contact McNeil Consumer Healthcare. Click here for additional recall instructions.

Triad Group Announces Povidone Iodine Prep Pad Recall

H&P Industries (operating as the Triad Group) is recalling all lots of their povidone iodine prep pads over the concern that they could be contaminated with Elizabethkingia meningoseptica. Use of the prep pads could lead to life-threatening infections, especially in at-risk populations such as neonates, surgical patients and people with suppressed immune systems.

Many of these prep pads were private labeled for other distributors. Affected povidone iodine prep pads can be identified by the following labels:
Item #AC-3201 (Amerinet)
Item #04-3201 (Cardinal Health)
Item #06-3201 (Versapro/Medical Specialities)
Item #08-3201 (Novation/VHA)
Item #10-3201 (Triad)
Item #11-PP32 (Triad+)
Item #PL-3533 (Total Resources)
Item #PL-3534 (North Safety)

Please click here to view recall instructions from the FDA.

Qualitest Pharmaceuticals Recalls Mislabeled Medications

Qualitest Pharmaceuticals has announced that it is recalling specific lots of hydrocodone bitartrate and aacetaminophen tablets and phenobarbital tablets. The recall comes after a 60-count bottle of hydrocodone bitartrate and aacetaminophen tablets was found incorrectly labeled as phenobarbital tablets.

This mislabeling could cause patients to unintentionally ingest hydrocodone and aacetaminophen tablets instead of the intended dose of phenobarbital. This mix-up could lead to serious adverse events. Patients who accidentally ingest hydrocodone could experience respiratory depression, central nervous system (CNS) depression, coma and death. The risks are especially high for opioid naive patients and those who are on other CNS depressants. Unintentionally ingesting acetaminophen could lead to liver toxicity in patients who are taking other acetaminophen-containing medications, patients with liver dysfunction and people who consume three or more alcoholic drinks a day. Missing doses of phenobarbital could result in loss of seizure control.

Affected lots of the medications were distributed to wholesale and retail pharmacies between September 21, 2010 and December 29, 2010. To learn  more and view affected lot numbers, click here.

Urgent Triad Group Product Recall

Professional Medical, Inc. recently received notification of a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS and ALCOHOL SWABSTICKS manufactured by the Triad Group. This recall involves both products marked as sterile and non-sterile products.

This recall has been initiated due to customer concerns about potential contamination of the products with an objectionable organism that may or may not be related to Triad's manufacture of these products. Triad is, out of an abundance of caution, recalling these lots and revalidating their production lines to ensure that they are not the source of these contamination issues.

This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.

Please examine all storage rooms, med rooms, med carts and treatment carts and inform nurses to be aware of the issue at hand.

Affected items might be listed under the following three item numbers from ProMed:
• 500-P200A-L
• 500-P100
• 500-TW100A

If you are ProMed customer, please take the following steps whether you have the products subject to recall in your possession or not:
1. Quarantine the affected product, if applicable
2. Email Pam West, VP of Clinical and Regulatory Compliance, at pwest@promedsupply.com for a Product Recall Acknowledgement Form.

Upon notification from the Triad Group of replacement details, Professional Medical will contact you with further instructions.

If replacement product is needed immediately, ProMed’s Compliance® Alcohol Prep Pads (600-P200A) are available and not affected by this recall.

We apologize for any inconvenience this might cause you and your staff. Please be assured that we are here to help. If you have any questions, we invite you to contact our Customer Relations Department at 800-648-5190.

Urgent Medical Device Recall: Triad Group Recalls Sterile Lubricating Jelly

Professional Medical, Inc. recently received notice from the Triad Group regarding an URGENT MEDICAL DEVICE RECALL. The product being recalled is STERILE LUBRICATING JELLY manufactured by the Triad Group and distributed by a number of companies, including Professional Medical.

This recall has been initiated due to concerns expressed by the Food and Drug Administration (FDA) regarding the validation of the gamma radiation sterilization cycles for the Sterile Lubricating Jelly. The use of inadequately sterilized product might result in patient infection.

This recall extends to all lots of Sterile Lubricating Jelly remaining within their labeled expiration dating (three years), including all lot numbers beginning with the digits 7, 8 and 9 and 0. These product lots began shipping in January of 2007.

Please examine all storage rooms, med rooms, med carts and treatment carts and inform nurses to be aware of all insertion kits that might contain lubricating jelly.

Affected items might be listed under the following three item numbers from ProMed:
• 500-LJ04
• 500-LJ144-3GM
• 500-LJ12-04FT

Whether you have the product subject to recall in your possession or not, please take the following steps:
1. Quarantine the affected product, if applicable
2. Email Pam West, VP of Clinical and Regulatory Compliance, at pwest@promedsupply.com for a Product Recall Acknowledgement Form.

If product is needed immediately, a replacement product (065-20545) is available from another manufacturer. Please note there is a difference in price.

We apologize for any inconvenience this might cause you and your staff. Please be assured that we are here to help. If you have any questions, please contact the Customer Relations Department at 800-648-5190.

Abbott Recalls Blood Glucose Test Strips

Abbott Diabetes Care has announced that they are recalling approximately 359 million blood glucose strips in the U.S. and Puerto Rico because they could give falsely low blood glucose results. These inaccurate readings could lead users to try and raise their blood glucose when it is unnecessary and fail to treat elevated blood glucose due to a falsely low reading.

According to a press release from Abbott, the problem is being caused by longer-than-expected blood fill times. Customers who are using the affected strips should discontinue use of the product. The affected brands are Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima.

Customers are advised to contact their healthcare providers to determine testing options if they do not have any unaffected test strips to use. To view affected lot numbers and instructions for receiving new strips, please click here.

FDA, Cardiac Science Announce AED Recall

Cardiac Science and the FDA are notifying healthcare professionals and consumers of a Class 1 recall of Cardiac Science's automated external defibrillators (AEDs). The affected units might not deliver therapy during a resuscitation attempt, and the malfunctioning might not be detected during the unit's self-tests.

Other problems with the units might include interruption of ECG analysis that prevent shock delivery, failure to recognize pad placement during use and interference or background noise that makes the device unable to accurately analyze the heart rhythm and deliver a shock, even if the ECG analysis was successfully conducted.

These problems could potentially lead to adverse health effects or even death.

Affected models include:

• Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
• CardioVive 92531, 92532, 92533
• NK 9200G, 9231
• Responder 2019198, 2023440

To learn more, click here.

Welch Allyn AED 10 Recall Information

Welch Allyn has recalled specific lots of its AED 10 defibrillator. To learn which lots were recalled and the potential risks associated with them, click here.

If you have purchased affected parts for an AED 10 from ProMed, please contact us at 1.800.648.5190. We will assist you in notifying Welch Allyn of the recalled unit.

Select Covidien Shiley Tracheostomy Tubes Recalled

Covidien is recalling certain lots of its Shiley tracheostomy tubes and custom/specialty tubes among reports of leaks in the tubes' pilot balloons. If there are leaks in the balloons, the cuffs aren't able to hold air, causing ventilation to not work properly and possibly resulting in a decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the resident requires assisted mechanical ventilation. The FDA advises that these situations could result in serious injury or even death.

If you have purchased tracheostomy products with any of the affected lot numbers from ProMed, please call Janice at our corporate office for assistance with a replacement. Janice can be reached at 800-648-5190, x 7616.

To view the lot numbers being recalled, click here.

Inaccurate Readings Prompt LifeScan Test Strip Recall

LifeScan, Inc. is voluntarily recalling eight lots of its OneTouch SureStep Test Strips. According to the manufacturer, the strips are being recalled because they may provide falsely low glucose results, which could lead to poor blood glucose control.

The eight lots of strips that are being recalled are:
#2969251 (100-ct OneTouch SureStep)
#2969798 (100-ct OneTouch SureStep)
#2982369 (100-ct OneTouch SureStep)
#2983467 (100-ct OneTouch SureStep)
#2969795 (50-ct OneTouch SureStep)
#2982566 (50-ct OneTouch SureStep)
#2969481 (50-ct OneTouch SureStep - Medicare/Mail Order)
#2998193 (50-ct OneTouch SureStep - Medicare/Mail Order)

Lot numbers can be found on outer cartons and test strip vials. For more information on the recall, click here.

If you're affected by this recall and you're considering choosing a different product, we hope you'll contact ProMed to learn about our Compliance Solutions!

McNeil Recalls OTC Products with Mildew-Like Odor

McNeil Consumer Healthcare announced on January 15 that they are voluntarily recalling certain lots of OTC products in the Americas, United Arab Emirates and Fiji. The recall was issued following consumer reports of an unusual mildew-like odor that resulted in nausea, stomach pain, vomiting or diarrhea in a small number of cases. The recall was taken in consultation with the FDA.

Upon investigation, McNeil determined that the smell was caused by the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials.

In December of 2009, McNeil recalled all lots of Tylenol Arthritis Pain 100 with EZ-Open Cap in relation to the same issue.

Affected products include certain lots of the following:

• Tylenol
• Motrin
• Benadryl Allergy Ultratab
• Rolaids Antacid Tablets
• Simply Sleep
• St. Joseph

To learn how to return the affected products and to view a complete listing of the recalled product lots, please click here.

If your facility is looking for an alternative to any of these products in light of the recall, ProMed has a wide variety of OTC products immediately available.

Hospira Announces Urgent Device Recall

Hospira, Inc. has issued an Urgent Device Recall for certain IV gravity and pump administration sets with CAIR Roller Clamps. The company is voluntarily recalling specific lot numbers of the products, manufactured by Borla S.P.A. of Italy.

If you have purchased ProMed item number 001-11540-58, lot number 600-194W, IV Sets w/Y Injection Site Primary 80" Disp ST (48/cs), during the time period of the recall (since December of 2006), please do a facility-wide search for the product - check every storage room, med room, resident cabinet, etc.

If you locate this product in your facility, it needs to be returned to ProMed immediately. We appreciate your cooperation!

Blair Expands Chenille Product Recall

Blair LLC, in conjunction with the Consumer Product Safety Commission, has issued an expanded recall of its chenille products after reports of the items catching fire. The company first issued a recall of 162,000 chenille robes in April of 2009 amid reports of the robes catching on fire while being worn, including several incidents that resulted in death. After this initial recall, the company learned of four additional deaths allegedly linked to the robes catching fire while being worn by elderly women in their 70s and 80s. So far, a total of nine deaths have been reported to Blair, all of which occurred before the product recall in April.

Blair has expanded the recall to include all chenille products from A-One Textile & Towel of Pakistan. This includes the following products:

• Full Length Women’s Chenille Robes
• Women’s Chenille Jacket
• Women’s Chenille Lounge Jacket
• Women’s Chenille Top

Blair has since severed ties to A-One. To learn more about the recall, including specific product item numbers, click here.

FDA: Power Cords Linked to Sparking, Charring and Fires

On October 19, The FDA announced that they are investigating defective medical device power cords. So far, the FDA has received 122 reports of defective power cords from Hospira, Inc. and Abbott Nutrition. These two companies have reported sparking, charring and fires from the cords in question. The root of the problem appears to be the power cord's prongs cracking or failing at/or inside the plug (see the FDA-released image above). The risks associated with power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure and fires. The FDA also notes that, depending on the device and therapy, these failures might lead to serious health consequences, including death.

All 122 of the reports from Hospira and Abbott involved AC power cords manufactured by the Electri-cord Manufacturing Company. The FDA knows Electri-cord has supplied cords to other medical device manufacturers and the agency is currently trying to determine which additional devices are equipped with these cords. While the FDA's investigation continues, the agency is recommending that all users of medical devices closely monitor the wear and tear on these devices' power cords. It's especially important to pay close attention to to any devices used in oxygen-rich settings in which sparking and arcing could trigger a fire.

To view the cord in question and learn more about actions that should be taken in the event of cord failure, click here. The FDA will continue to provide updated information as soon as it is available.