Date Initiated by Firm | September 03, 2003 |
Date Posted | September 23, 2003 |
Recall Status1 |
Terminated 3 on May 06, 2012 |
Recall Number | Z-1264-03 |
Recall Event ID |
27162 |
Product Classification |
Instrument, Surgical, Disposable - Product Code KDC
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Product | 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 EMS Endo Hernia , item # 8034. |
Code Information |
All codes. |
Recalling Firm/ Manufacturer |
International Surgical Supply, Inc. 8585 NW 72nd St. Miami FL 33166
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For Additional Information Contact | James M. Vogt 305-471-7390 |
Manufacturer Reason for Recall | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. |
FDA Determined Cause 2 | Other |
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. |
Quantity in Commerce | 6 boxes of 6 each |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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