FDA Medical Device Recalls (openFDA)
Bard Endoscopic Technologies: Bard PEG Safety System ''Guidewire'' Reorder Number: 000930
- Recall number
- Z-1230-03
- Recalling firm
- Bard Endoscopic Technologies
- Product
- Bard PEG Safety System ''Guidewire'' Reorder Number: 000930
- Status
- Terminated
- Initiated
- 2003-08-04
- Posted
- 2003-09-11
- Terminated
- 2006-04-05
- 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
- 522 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
- Lot, serial or model codes
- Lot Number: 43FNA080, 43FNA081, 43FNA179
- 510(k) numbers
- ["K980987"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1000159712
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28