Agency classClass IIOur severity:High FDA (Devices)·Z-1291-2014·Announced 2014-04-02

Teleflex Medical Recalls Non-absorbable Polyamide Surgical Sutures

Teleflex Medical is recalling 32,271 units of non-absorbable polyamide surgical sutures because they failed to meet minimum needle attachment strength requirements.

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 structural defect (needle attachment strength) that poses a risk of harm during surgical use, 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 non-absorbable, synthetic, polyamide surgical sutures. The product is sterile and intended for prescription use in soft tissue approximation. The recall covers product code 1154654, lot number 02K0801212.

The recall was initiated because the products did not meet minimum needle attachment strength requirements. The affected units were distributed worldwide, including the United States, Canada, Germany, and Ireland.

Healthcare providers and patients should stop using the affected sutures and contact Teleflex Medical for further instructions or a replacement.

The recalled product

Product: Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue…
Manufacturer: Teleflex Medical
Category: Medical Device — Surgical Suture
Hazard: structural-defect
needle-detachment
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 (2)

Product Code: 1154654
Lot number: 02K0801212

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · Teleflex Medical

See all →

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Same hazard · structural defect