Z-1233-03

Bard PEG Safety System ''Guidewire'' Reorder Number: 001928

Name: Z-1233-03 Bard PEG Safety System ''Guidewire'' Reorder Number: 001928
Creator: Bard Endoscopic Technologies
Published: 2003-08-04
License: https://open.fda.gov/license/

Conmed Endoscopic Technologies, Inc. / initiated 2003-08-04 / Terminated / root cause: labeling and UDI

FDA source

Bard Endoscopic Technologies began a recall of Bard PEG Safety System ''Guidewire'' Reorder Number: 001928 on 2003-08-04. The reason FDA records is "Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1233-03
Status: Terminated
Initiated: 2003-08-04
Posted: 2003-09-11
Terminated: 2006-04-05
Recalling firm: Conmed Endoscopic Technologies, Inc.
Product: Bard PEG Safety System ''Guidewire'' Reorder Number: 001928
Product code: FMF Syringe, Piston
Reason for recall: Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 2 units
Distribution: 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
Product codes and lots: Lot Number: 43FNA090

Product code FMF

K980987Class IIBecton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1998-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)