The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1292-2014·Announced 2014-04-02

Teleflex Medical Recalls Non-absorbable Surgical Sutures for Needle Attachment Defect

Teleflex Medical is recalling non-absorbable poly(ethylene terephthalate) surgical sutures because they did not 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 surgery, 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 specific lots of non-absorbable, synthetic, poly(ethylene terephthalate) surgical sutures. These sterile, multifilament threads are indicated for use in soft tissue approximation. The recall involves a total of 32,271 units.

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

The affected products were distributed worldwide, including the United States, 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
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear…
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: 0100019-507
  • Lot number: 02F1301128
  • Product Code: 6-511
  • Lot number: 02M0800561
  • Product Code: 6-559
  • Lot number: 02A0800005
  • Product Code: 69-403
  • Lot number: 02H0802530
  • Product Code: 7-5008M4
  • Lot number: 02C0900466
  • Product Code: 7-518
  • Lot number: 02E1302561
  • Product Code: 7-565
  • Lot number: 02B1100185
  • Product Code: 7-655A
  • Lot numbers: 02C0901963 & 02M0800836
  • Product Code: 7-740
  • Lot number: 02L1000536
  • Product Code: 833-114
  • Lot numbers: 02A1202112

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 →

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