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U.S. Department of Health and Human Services

Class 2 Device Recall Monofilament and Multifilament Nonabsorbable Steel Suture

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  Class 2 Device Recall Monofilament and Multifilament Nonabsorbable Steel Suture see related information
Date Initiated by Firm March 11, 2014
Date Posted April 24, 2014
Recall Status1 Terminated 3 on December 17, 2015
Recall Number Z-1497-2014
Recall Event ID 67895
510(K)Number K930738  
Product Classification Suture, nonabsorbable, steel, monofilament and multifilament, sterile - Product Code GAQ
Product Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
Code Information Product Code: 0520197-2, Lot number: 02H1001071; Product Code: 29-727, Lot numbers: 02M1101954, 02C1201003, and 02C1201646; Product Code: 29-7270M4, Lot number: 02D1100604; Product Code: 29-7281M4, Lot number: 02M1002679; Product Code: E29-5553M4, Lot number: 02B1300245; Product Code: E29-7270M4, Lot number: 02J1001576; Product Code: E29-7272M4, Lot number: 02D1003015; Product Code: E29-727A, Lot number: 02F1101062; Product Code: EP4013P, Lot number: 02L0800898; Product Code: EP4110N, Lot number: 02H0900483; Product Code: X-2235, Lot numbers: 02E1102068, 02F1101041, 02F1201500, and 02G1201230; Product Code: X29-7271M2, Lot number: 02K1100784; Product Code: X-5667M8 and Product Code: X-6730M5, Lot number: 02G1300492.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall		 The products are being recalled because they did not meet minimum diameter requirements.
FDA Determined
Cause 2		 Other
Action Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected constomers. The letter identified the affected product, problem and actions to be taken. Customers were instructed if they have affected stock immediately discontinue use, quarantine, and return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgement Form and Fax it to 1-508-964-6078, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-508-964-6042.
Quantity in Commerce 3,816 ea
Distribution Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.
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 = GAQ and Original Applicant = DEKNATEL, INC.
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