FDA Device

Bard PEG Safety System ''Guidewire'' Reorder Number: 000930

Hazard

Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile

What You Should Do

Remedy

Bard Endoscopic notified customerson 8/4/03, by Recall Notice sent by registered mail, along with an Effectivity Form that each Bard account will complete and return. Product will be returned to Bard Endoscopic. 5. The BET Recall Coordinator will track effectivity, and phone accounts that have either not returned the Effectivity Form or whose letter had been returned as undeliverable.

Products

Bard PEG Safety System ''Guidewire'' Reorder Number: 000930
Brand
Bard Endoscopic Technologies
UPC
Lot Number: 43FNA080, 43FNA081, 43FNA179

Units Affected

522 units