Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007036, 24F, Sterile.

FDA Recall Z-2192-2009 · Posted 2009-09-15

Recalling FirmC.R. Bard Access Systems, Inc
Recall StatusTerminated
Product CodeKNT
Date Initiated2008-12-04
Date Terminated2011-11-09
Product Quantity177,614 units

Reason for Recall

Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

Firm Action

Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide, including USA, Belgium, Canada, Australia, and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061021ENTAKE STANDARD AND SAFETY PEG SYSTEMConmedcorp · 2006-04-28K033562FASTRAC GASTRIC ACCESS PORT KITC.R. Bard, Inc. · 2003-12-12K972025RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KITRadius Intl., Inc. · 1998-01-23K972101SOLITAIREHeraeus Kulzer, Inc. · 1997-09-29K915841BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPICC.R. Bard, Inc. · 1993-06-25

Official Source

View FDA Recall →

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

↑