The Recall Desk
HighFDA (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.

What this means for you

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 fo
Manufacturer
Teleflex Medical
Category
Medical Device — Surgical Sutures
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 (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 →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · structural defect

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