FDA Alerts/Recall: Several infusion related products

In the past weeks, there have several FDA alerts and recall notices related to products used in infusion therapy. Here are some of the products.

Class I Recall: CareFusion Corporation, Alaris PC Units (Model 8015) Reason for Recall:
Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions.

If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy. This could lead to serious injury and/or death.

If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.

Class I Recall: Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall – Potential Loss of Sterility
Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.

Consumers who have 5ml fill in 6 cc saline pre-filled syringes manufactured by Excelsior Medical should immediately discontinue using these syringes and return them to the point of purchase.

Voluntary Recall: Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall – Presence of Glass Particulates
Sandoz and FDA notified healthcare professionals of a recall of Methotrexate Injection, 50mg/2mL and 250mg/10mL vials, due to small glass flakes detected in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of the two dosage presentations.

Parenteral injection of drug from the affected lots could lead to serious adverse events in areas where the particles lodge. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Neurologic damage could result from intrathecal administration.

Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Product lot numbers, label type, expiration dates, and recall instructions are listed here.

Voluntary Recall: Heparin Sodium (B. Braun): Recall – Trace Contaminant
B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.

Customers who have product from the recalled product lots in their possession should discontinue use immediately. Product lot numbers, expiration dates, and recall instructions are listed here.

For more information, visit the FDA MedWatch site, click here.