Teleflex Recalls Deknatel Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel nonabsorbable sutures because the needle may detach from the suture during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 functional defect (needle detachment) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 32,271 units of Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. The product is indicated for use in soft tissue approximation. The recall involves Product Code 1154654, Lot 02K0801212.
The recall was initiated because the product does not meet minimum needle attachment strength requirements. This defect means the needle can become detached from the suture during use.
The affected products were distributed worldwide, including in the United States (specifically AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI) and in Canada, Germany, and Ireland. Healthcare providers and facilities should stop using the affected lots and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
- Manufacturer
- Teleflex Medical
- Hazard
- 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 (1)
- Product Code 1154654 - Lot 02K0801212
Distribution
Part of a larger recall action
This product is one of 7 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.
See all 7 products in this recall →Related recalls
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Similar recalls
- HighTeleflex Medical Recalls Non-absorbable Surgical Sutures for Needle Attachment Defect
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect
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