Teleflex Medical Recalls Fixt Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures because the needles may detach during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (needle detachment) during use, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Teleflex Medical is recalling 32,271 units of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures. These are synthetic absorbable surgical sutures indicated for use in soft tissue approximation. The recall involves specific product codes and lots, including Product Code BON100 (Lots 02H1302839, 02J1101705, 02D1101137, 02F1103013) and Product Code EP4049N (Lot 02A1003137).
The recall was initiated because the product does not meet minimum needle attachment strength requirements. Consequently, the needle can become detached from the suture during use. This defect poses a risk of injury to patients during surgical procedures.
The affected products were distributed worldwide, including in the United States (specifically in states such as 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 in Canada, Germany, and Ireland. Healthcare providers and facilities should check their inventory for the listed product codes and lots and stop using these sutures immediately.
The recalled product
- Product
- Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
- Manufacturer
- Teleflex Medical
- Affected units
- 32,271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product Code BON100 - Lot 02H1302839
- 02J1101705
- 02D1101137
- 02F1103013
- Product Code EP4049N - Lot 02A1003137
Distribution
Part of a larger recall action
This product is one of 7 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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