FDA Medical Device Recalls (openFDA)
Vanguard Medical Concepts, Inc: Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
- Recall number
- Z-1212-06
- Recalling firm
- Vanguard Medical Concepts, Inc
- Product
- Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
- Status
- Terminated
- Initiated
- 2006-03-17
- Posted
- 2006-07-12
- Terminated
- 2008-10-31
- Reason
- Review of complaints and testing show that the distal tip of the trocars may separate while in use.
- Root cause
- Package design/selection
- Action
- The firm sent recall notification letters to its consignees on 3-17-2006. They were instructed to discontinue use of the 35NLT, 35NST and 35Ol Reprocessed Optiview Trocars with expiration date of 12/20008 or earlier immediately. Any of this product in inventory were to be returned to the manufacturer for credit. The firm also offered the assistance of its representatives in returning all affected profucts. The investigation is ongoing, and corrective actions associated with the root cause of tips breaking off have been identified and are being implemented.
- Quantity
- 13,842
- Distribution
- Nationwide.
- Lot, serial or model codes
- All lot numbers produced before January, 1, 2006. (Product with expiration date of 12/20008 or earlier.)
- 510(k) numbers
- K043253
- PMA numbers
- not on file
- Product code
- NLM
- Firm FEI
- 1000132435
- Firm city
- Lakeland
- Firm state
- FL
- 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