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U.S. Department of Health and Human Services

Class 2 Device Recall Ethicon

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 Class 2 Device Recall Ethiconsee related information
Date Initiated by FirmSeptember 03, 2003
Date PostedSeptember 23, 2003
Recall Status1 Terminated 3 on May 06, 2012
Recall NumberZ-1269-03
Recall Event ID 27162
Product Classification Instrument, Surgical, Disposable - Product Code KDC
ProductETHICON 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: Trocar, Tristar, blunt tip, item 512B.
Code Information all codes.
Recalling Firm/
Manufacturer		 International Surgical Supply, Inc.
8585 NW 72nd St.
Miami FL 33166
For Additional Information ContactJames 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
ActionThe 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 Commerce18
DistributionProduct 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 CycleTPLC Device Report
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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