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.
This recall has been terminated (originally issued May 7, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- March 11, 2014
- Posted
- May 7, 2014
- Terminated
- August 14, 2017
- Recall Number
- Z-1557-2014
- Quantity
- 32,271 ea.
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
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.
Lot / Code Info
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.
Root Cause
Employee error
Action Taken
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.