BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G

FDA device recall Z-1274-2015 · posted 2015-03-13 · Terminated

Recall details

Recalling firm

Bard Access Systems

Reason for recall

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Action taken

The firm, BD Medical, sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated July 22, 2014 and a follow-up "URGENT: Voluntary Product Recall-BD PosiFlush SF Saline Flush Syringe 10mL with rework instructions for applicable Bard Kits" letter dated August 8, 2014 to its customers and distributors. The letters described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory and quarantine product subject to the recall; complete and return the Recall Response Card form via fax to BD at 1-201-847-6990 or email to Becky_Saggau@bd.com and return all affected products. Note: If you do not have any of the affected lots in your inventory, please complete the Recall Response Card form indicating you have (0) quantity and fax or email. The distributors were instructed to immediately examine your inventory and identify any product subject to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this notification. Complete the attached Recall Reply Form and FAX to Bard Access Systems, Inc. at 1-801-522-5674, or EMAIL to BASD.fieldaction@crbard.com. Even if you do not have any inventory of the affected syringe lots. Please direct any return requests and questions to our coordinator at 800-290-1689. If you have any questions or require assistance with the return of the recalled product and/or availability of replacement product, please contact BD Customer Service at 1-888-237-2762 option 3.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FOZ

Quantity affected

4375 units

Distribution

US Nationwide Distribution.

Date initiated

2014-08-08

Date posted

2015-03-13

Date terminated

2015-08-05

Location

Salt Lake City, UT

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