Agency classClass IIOur severity:High FDA (Devices)·Z-1294-2014·Announced 2014-04-02

Teleflex Medical Recalls Polyglycolic Acid Sutures for Needle Attachment Defects

Teleflex Medical is recalling 32,271 units of absorbable polyglycolic acid 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 is classified as FDA Class II, and the hazard involves a structural defect (needle attachment strength) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Teleflex Medical is recalling 32,271 units of Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile. The recall is being conducted because the products did not meet minimum needle attachment strength requirements. The affected product code is BON100, and the specific lot numbers are 02H1302839, 02J1101705, 02D1101137, and 02F1103013.

The affected sutures were distributed worldwide, including the United States, Canada, Germany, and Ireland. The source text does not specify the exact number of units distributed in each specific location or the specific medical facilities that received the product.

Healthcare providers and consumers should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor in accordance with the recall instructions.

The recalled product

Product: Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated…
Manufacturer: Teleflex Medical
Category: Medical Device — Surgical Sutures
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 (5)

Product Code: BON100
Lot numbers: 02H1302839
02J1101705
02D1101137
and 02F1103013.

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

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Same hazard · structural defect