Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P,Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P,Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P
This recall has been terminated (originally issued July 17, 2007).
- Recall Initiated
- June 6, 2007
- Posted
- July 17, 2007
- Terminated
- March 14, 2008
- Recall Number
- Z-1013-2007
- Quantity
- 1920 units total for all types of sutures
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Lot / Code Info
Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P, Lot #3328445; Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Lot #3313774 & 3200044; Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Lot #2297080 & 2467234; Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Lot #2486461; Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P, Lot #2351154; Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Lot #2351154; Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Lot #2306894 & 3308136; Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P, Lot #2324039; Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Lot #2262121 & 2306894; Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Lot #2306897; Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Lot #3211901& 3346174; Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Lot #2306899 & 2306900; Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Lot #3335219; Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P, Lot #3335220.
Root Cause
Other
Action Taken
Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.