Bard Ponsky PEG Safety System ''Pull'' Reorder Number: 001925
FDA device recall Z-1231-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Bard Endoscopic Technologies
- Reason for recall
- Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
- Action taken
- 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
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 6 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
- Date initiated
- 2003-08-04
- Date posted
- 2003-09-11
- Date terminated
- 2006-04-05
- Location
- Billerica, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BECTON DICKINSON SYRINGE (K980987) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-11 |