Teleflex Medical Recalls Bard Fixt Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the potential for significant injury during a surgical procedure if the needle detaches.
Plain-English summary
Teleflex Medical is recalling Bard Fixt Suture Braided Polyester, a prescription-only medical device indicated for soft tissue approximation. The recall involves 32,271 units of Product Code H5300, Lot 1450153E13. The product was distributed worldwide, including in the United States, Canada, Germany, and Ireland.
The recall was initiated because the product does not meet minimum needle attachment strength requirements. This defect creates a risk that the needle can become detached from the suture during use.
Healthcare providers and facilities that have received this product should stop using it and contact Teleflex Medical for further instructions. Consumers should not use this product and should contact their healthcare provider if they have questions regarding its use.
The recalled product
- Product
- Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. 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 (1)
- Product Code H5300 - Lot 1450153E13
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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