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: 5mm Curved Shears, Scissors Grip Handle 14cm Item Code CS14C.
FDA Recall Z-1258-03 · Posted 2003-09-23
Recalling FirmInternational Surgical Supply, Inc.
Recall StatusTerminated
Product CodeKDC
Date Initiated2003-09-03
Date Terminated2012-05-06
Product Quantity13 boxes ( 12 per box)
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.