• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Suture, Nonabsorbable, Synthetic, Polyethylene

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Suture, Nonabsorbable, Synthetic, Polyethylene
see related information
Date Posted May 07, 2014
Recall Status1 Open
Recall Number Z-1557-2014
Recall Event ID 67711
Premarket Notification
510(K) Number
K930738 
Product Classification Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile - Product Code GAQ
Product Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
Code Information Product Code 833-123 - Lot 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, 02K1102309, Product Code 833-124 - Lot 02A1200503, 02B1101450, 02C0903400, 02D0900010, 02D0900103, 02D1003285, 02D1003286 02F1302321, 02G1000045, 02G1300348, 02G1301122, 02H1100494, 02L0803407, 02L1100009, 02M1002289, 02M1101933, 02F1302322, Product Code 833-213 - Lot 02H1100687, Product Code D-5007K - Lot 02B1002310, 02C1103731, 02F1100069, 02H1102294, Product Code D-5007M4A - Lot 02M0902844, Product Code D-5007M4K - Lot 02C1002252, 02F1100124, Product Code D-7016M4K - Lot 02G1301749, Product Code D-7070K - Lot 02A1103450, 02B1002276, Product Code D-7070M4K - Lot 02C1103707, 02F1301100, 02G1100876, 02G1301739, 02F1101036, 02J1301343, 02K0900010, Product Code D-7076M1K - Lot 02H1103237, Product Code D-7375K - Lot 02A1201015, Product Code D-793M4K - Lot 02L1002488, Product Code ED-6072 - Lot 02C1002218, 02E1002342, 02J0902517, Product Code ED-6276 - Lot 02F0902457, Product Code ED-6896 - Lot 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, 02G1301755, Product Code ED-852 - Lot 02G1002594, Product Code ED-863 - Lot 02B0902976, 02D0902457, 02M0901348.
Recalling Firm/
Manufacturer
Teleflex Medical
4024 Stirrup Creek Dr
Durham, North Carolina 27703-9000
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
Quantity in Commerce 32,271 ea.
Distribution Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GAQ and Original Applicant = DEKNATEL, INC.
-
-