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Terminated

Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725

FDA Recall Z-0413-03 · Posted 2003-01-09

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHRX
Date Initiated2002-11-08
Date Terminated2005-04-20
Product Quantity77 units

Reason for Recall

Potential for non sterility as package tray does not contain aeration holes for ETO processing.

Firm Action

Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.

Root Cause

Process control

Distribution Pattern

Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931621ACUFEX PRO-PAC AND ISO-PACAcufex Microsurgical, Inc. · 1994-01-21

Official Source

View FDA Recall →

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

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