Teleflex Recalls CAPIO Absorbable Surgical Sutures for Strength Defects
Teleflex Medical is recalling CAPIO absorbable surgical sutures because they did not meet minimum resorption strength requirements. The recall affects 7,380 units distributed in the US, Ireland, and Singapore.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a performance defect (resorption strength) without reported adverse health consequences, fitting the 'Moderate' criteria for low-risk or precautionary recalls.
Plain-English summary
Teleflex Medical is recalling CAPIO, Monodeck, Violet Monofilament Polydioxanone Sutures, 1 x 48 inches (122cm), Product Code 833-137. The recall involves 7,380 units of the absorbable surgical suture. The product was distributed nationwide in the United States (specifically in CA, CO, GA, LA, IL, MA, MI, MN, MO, and NC) as well as in Ireland and Singapore.
The recall was initiated because the product did not meet minimum and/or average minimum Teleflex resorption strength requirements. This defect could potentially affect the performance of the suture during surgical procedures.
Healthcare providers and patients should check their inventory for the specific lot numbers listed in the recall notice: 02A0901938, 02B0901537, 02H1001025, 02H1001026, 02H1001027, 02C1102979, 02C1102983, 02D1300294, 02D1301164, 02C1302078, and 02D1302468. Affected units should be quarantined and returned to Teleflex Medical for credit or replacement.
The recalled product
- Product
- CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Surgical Suture
- Hazard
- Affected units
- 7,380
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 (12)
- Product Code: 833-137
- Lot numbers: 02A0901938
- 02B0901537
- 02H1001025
- 02H1001026
- 02H1001027
- 02C1102979
- 02C1102983
- 02D1300294
- 02D1301164
- 02C1302078
- 02D1302468.
Distribution
Part of a larger recall action
This product is one of 2 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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