FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.
- Recall number
- Z-0467-06
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.
- Status
- Terminated
- Initiated
- 2005-11-17
- Posted
- 2006-02-04
- Terminated
- 2008-03-03
- Reason
- The catheter connector could not be sufficiently tightened to secure the catheter tubing.
- Root cause
- Other
- Action
- Recall letters were sent to all direct consignees and potential end users of the product on 11/17/2005. Letters were mailed via UPS second day air.
- Quantity
- 1410 units
- Distribution
- The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.
- Lot, serial or model codes
- Reorder Number 400507 Lot Number 5222801.
- 510(k) numbers
- ["K850505"]
- PMA numbers
- not on file
- Product code
- GCD
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- 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