Teleflex Recalls Dekna-lok Sutures for Failing Resorption Strength Requirements
Teleflex Medical is recalling 7,380 units of Dekna-lok sutures because they did not meet minimum resorption strength requirements. The affected products were 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, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or deaths, and the defect is a failure to meet internal strength requirements rather than a contamination or structural failure causing immediate harm.
Plain-English summary
Teleflex Medical is recalling 7,380 units of Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture. The recall involves specific product codes and lot numbers: Product Code 200101-01 (Lot # 02F0801290) and Product Code BP1000V2L (Lot numbers 02C1003535 & 02F1000711). These are synthetic absorbable surgical sutures intended for prescription use only.
The recall was initiated because the product did not meet minimum and/or average minimum Teleflex resorption strength requirements. The affected units were distributed worldwide, specifically in the United States (California, Colorado, Georgia, Louisiana, Illinois, Massachusetts, Michigan, Minnesota, Missouri, and North Carolina), Ireland, and Singapore.
Healthcare providers and facilities that have received these products should stop using them and contact Teleflex Medical for further instructions. Patients who have had these sutures used in a procedure should consult their healthcare provider if they have concerns regarding the resorption strength of the material.
The recalled product
- Product
- Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
- 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 (3)
- Product Code: 200101-01
- Lot # 02F0801290 and Product Code: BP1000V2L
- Lot numbers: 02C1003535 & 02F1000711.
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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