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U.S. Department of Health and Human Services

Class 2 Device Recall Gyrus ACMI

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  Class 2 Device Recall Gyrus ACMI see related information
Date Initiated by Firm February 19, 2007
Date Posted March 13, 2007
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-0613-2007
Recall Event ID 37404
510(K)Number K932293  
Product Classification Forceps - Product Code KNS
Product Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
Code Information Lot Nos. : 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012
Recalling Firm/
Manufacturer		 Gyrus ACMI Corporation
136 Turnpike Rd
Southborough MA 01772-2118
Manufacturer Reason
for Recall		 Product sterility may be compromised due to failure of the tray seal packaging
FDA Determined
Cause 2		 Packaging process control
Action Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .
Quantity in Commerce 527 boxes (5 units/box)
Distribution Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = KNS and Original Applicant = CABOT MEDICAL CORP.
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