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Terminated

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

FDA Recall Z-1230-03 · Posted 2003-09-11

Recalling FirmBard Endoscopic Technologies
Recall StatusTerminated
Product CodeFMF
Date Initiated2003-08-04
Date Terminated2006-04-05
Product Quantity522 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide AZ, AL, CA, CO, CT, FL, GA, KY, IN, IL, KS, LA, MA, MD, MS, MN, MO, NH, NJ, NY, OH, MI, MO, PA, RI, TN, TX, VA, VT , WA Govt: VA MEDICAL CENTER/CC 800 HOSPITAL DR. COLUMBIA MO 06050

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980987BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic · 1998-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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