Teleflex Medical Recalls Non-absorbable Steel Sutures for Diameter Defects
Teleflex Medical is recalling specific lots of non-absorbable steel sutures because they did not meet minimum diameter requirements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a physical specification (diameter) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical is recalling 3,816 units of Monofilament and Multifilament Non-absorbable Steel Sutures. The recall involves specific product codes and lot numbers, including 0520197-2, 29-727, and X-2235.
The products are being recalled because they did not meet minimum diameter requirements. The affected units were distributed worldwide, including in California, Colorado, Florida, Indiana, Kentucky, Massachusetts, New Mexico, Pennsylvania, Canada, Ireland, and Germany.
Healthcare facilities and consumers should stop using the affected sutures and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 3,816
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 (20)
- Product Code: 0520197-2
- Lot number: 02H1001071
- Product Code: 29-727
- Lot numbers: 02M1101954
- 02C1201003
- and 02C1201646
- Product Code: 29-7270M4
- Lot number: 02D1100604
- Product Code: 29-7281M4
- Lot number: 02M1002679
- Product Code: E29-5553M4
- Lot number: 02B1300245
- Product Code: E29-7270M4
- Lot number: 02J1001576
- Product Code: E29-7272M4
- Lot number: 02D1003015
- Product Code: E29-727A
- Lot number: 02F1101062
- Product Code: EP4013P
- Lot number: 02L0800898
Distribution
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