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Terminated

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.

FDA Recall Z-0468-06 · Posted 2006-02-04

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeGCD
Date Initiated2005-11-17
Date Terminated2008-03-03
Product Quantity1410 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K850505DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTERParke-Davis Co. · 1985-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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