Teleflex Medical Recalls Silk Sutures Due to Needle Attachment Defect
Teleflex Medical is recalling 32,271 units of sterile silk sutures because they failed to meet minimum needle attachment strength requirements.
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 involves a medical device with a structural defect (needle attachment strength) that poses a risk of harm during surgical procedures, 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 Sutures, Non-absorbable, Silk, Sterile, Rx only. The affected product is identified by Product Code X-6371M5 and Lot number 02E0801603. These sutures are natural, non-absorbable, sterile, flexible multifilament threads composed of fibroin, indicated for use in soft tissue approximation.
The recall was initiated because the products did not meet minimum needle attachment strength requirements. This defect could potentially compromise the integrity of the suture during surgical use.
The affected units were distributed worldwide, including the United States, Canada, Germany, and Ireland. Healthcare providers and facilities should check their inventory for the specific lot number and product code listed above. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor.
The recalled product
- Product
- Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx
- 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 (2)
- Product Code: X-6371M5
- Lot numbers: 02E0801603
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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