Recall Z-1232-03 ยท FMF Syringe, Piston
Bard Endoscopic Technologies
Bard Ponsky PEG Safety System ''Pull'' Reoder Number: 001927
| Date | Sep 11, 2003 (initiated Aug 4, 2003) |
| Status | Terminated |
| Reason | Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile |
| 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 | 8 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980987 | BECTON DICKINSON SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic, Jun 11, 1998 |