—#43257

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.

FDA product code: GCD — Connector, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K850505
Affected lot / code info: Reorder Number 400507 Lot Number 5222801.

Why it was recalled

The catheter connector could not be sufficiently tightened to secure the catheter tubing.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.

Timeline

Recall initiated: 2005-11-17
Posted by FDA: 2006-02-04
Terminated: 2008-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43257. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.