Z-0468-06

BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components...

Name: Z-0468-06 BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components...
Creator: Becton Dickinson & Company
Published: 2005-11-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2005-11-17 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components: body (green), cap (white), washer (white), and gasket... on 2005-11-17. The reason FDA records is "The catheter connector could not be sufficiently tightened to secure the catheter tubing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0468-06
Status: Terminated
Initiated: 2005-11-17
Posted: 2006-02-04
Terminated: 2008-03-03
Recalling firm: Becton Dickinson & Co
Product: BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. 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.
Product code: GCD Connector, Catheter
Reason for recall: The catheter connector could not be sufficiently tightened to secure the catheter tubing.
FDA 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 in commerce: 1410 units
Distribution: The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.
Product codes and lots: Reorder Number 400273 Lot Number 5164796

Product code GCD

K850505Class IIDeseret Epidural Catheter W/toughy-Borst AdapterParke-Davis Co. / cleared 1985-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)