Agency classClass IIOur severity:High FDA (Devices)·Z-1293-2014·Announced 2014-04-02

Teleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect

Teleflex Medical is recalling non-absorbable polypropylene 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 defect involves a structural failure (needle attachment strength) in a surgical device, which poses a risk of harm even without reported injuries.

Plain-English summary

Teleflex Medical is recalling 32,271 units of non-absorbable, synthetic, polypropylene surgical sutures. These sterile, prescription-only medical devices are indicated for use in soft tissue approximation. The recall affects specific product codes and lot numbers distributed worldwide, including the United States, Canada, Germany, and Ireland.

The products are being recalled because they did not meet minimum needle attachment strength requirements. This defect could potentially affect the integrity of the suture during surgical use.

Healthcare providers and patients who have used or possess these specific lot numbers should contact Teleflex Medical for further instructions or a replacement. The recall is classified as Class II by the FDA.

The recalled product

Product: Sutures, Non-absorbable, Synthetic, Polypropylene, 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
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 (20)

Product Code: 833-123
Lot numbers: 02A0902858
02D0900775
02G1003092
02H1100535
02H1100536
& 02K1102309
Product Code: 833-124
Lot numbers: 02A1200503
02B1101450 & 02C0903400
Product Code: 02D0900010
02D0900103
02D1003285
02D1003286 & 02F1302321
Product Code: 02G1000045
02G1300348
02G1301122
02H1100494
& 02L0803407
Product Code: 02L1100009

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