Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel Silk 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. The hazard involves a surgical instrument failing during a procedure (needle detachment), which poses a significant risk of injury to the patient, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Teleflex Medical is recalling 32,271 units of Deknatel Silk Black Braided Silk Suture, Product Code X-6371M5, Lot 02E0801603. The recall was initiated because the product does not meet minimum needle attachment strength requirements.
The hazard is that the needle can become detached from the suture during use. This nonabsorbable surgical suture is indicated for use in soft tissue approximation.
The affected product was 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
- Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
- 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 (1)
- Product Code X-6371M5 - Lot 02E0801603
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
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · needle detachment
See all →- HighBard Marquee Biopsy Instruments Recalled for Potential Needle Detachment
FDA (Devices) · 2024-11-27
- HighEasyPoint Needle may detach inside patient during use
FDA (Devices) · 2024-03-20
- HighSertera 14 Gauge Biopsy Device: Needle Detachment Risk
FDA (Devices) · 2023-07-05
- HighHaiou Needle Retractable Safety Syringe recalls due to needle detachment risk
FDA (Devices) · 2022-08-17
- HighHAIOU Retractable Safety Syringes Recalled for Needle Detachment Risk
FDA (Devices) · 2022-08-17
Similar recalls
- HighTeleflex Medical Recalls Silk Sutures Due to Needle Attachment Defect
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Non-absorbable Surgical Sutures for Needle Attachment Defect
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Non-absorbable Polyamide Surgical Sutures
FDA (Devices) · 2014-04-02
- HighTeleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect
FDA (Devices) · 2014-04-02
- ModerateTeleflex Recalls Dekna-lok Sutures for Failing Resorption Strength Requirements
FDA (Devices) · 2014-05-07
- HighTeleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect
FDA (Devices) · 2014-04-02