Teleflex Medical Recalls Polyglycolic Acid Sutures for Needle Attachment Defects
Teleflex Medical is recalling 32,271 units of absorbable polyglycolic acid 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 is classified as FDA Class II, and the hazard involves a structural defect (needle attachment strength) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Teleflex Medical is recalling 32,271 units of Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile. The recall is being conducted because the products did not meet minimum needle attachment strength requirements. The affected product code is BON100, and the specific lot numbers are 02H1302839, 02J1101705, 02D1101137, and 02F1103013.
The affected sutures were distributed worldwide, including the United States, Canada, Germany, and Ireland. The source text does not specify the exact number of units distributed in each specific location or the specific medical facilities that received the product.
Healthcare providers and consumers should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated fo
- 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 numbers: 02H1302839
- 02J1101705
- 02D1101137
- and 02F1103013.
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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