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

ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler, Articulating, Linear, item # AX55

FDA Recall Z-1267-03 · Posted 2003-09-23

Recalling FirmInternational Surgical Supply, Inc.
Recall StatusTerminated
Product CodeKDC
Date Initiated2003-09-03
Date Terminated2012-05-06
Product Quantity16

Reason for Recall

Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.

Firm Action

The firm sent an e-mail recall notification and request for response on 9/3/2003, to the one direct account in Minnesota requesting quarantine and return of product and also subrecall down to the hospital/health professional level.

Root Cause

Other

Distribution Pattern

Product was distributed to a direct consignee/distributor in Minnesota and also directly to the only two hospital/health professional accounts involved both in Tennessee.

Official Source

View FDA Recall →

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

↑