The Recall Desk
HighFDA (Devices)·Z-1509-2014·Announced 2014-04-30

Teleflex Recalls Monodek Violet Synthetic Absorbable Surgical Sutures

Teleflex Medical is recalling Monodek Violet Synthetic Absorbable Surgical Sutures because they do not meet minimum knot tensile 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 involves a medical device that fails to meet minimum performance requirements (knot tensile strength), posing a risk of harm in a surgical setting, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Teleflex Medical is recalling Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48. The recall involves 3,072 units of the product.

The recall was initiated because the product does not meet minimum knot tensile strength requirements. The affected product codes are 833-137, with batches 02H1103434, 02H1200349, and 02K1201354.

The product was distributed worldwide, including the United States (specifically Massachusetts) and Germany. Healthcare providers and facilities should stop using the affected sutures and contact Teleflex Medical for further instructions.

The recalled product

Product
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Manufacturer
Teleflex Medical
Affected units
3,072

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 (4)

  • Product Code: 833-137
  • Batch: 02H1103434
  • 02H1200349
  • and 02K1201354.

Distribution

Distributed in 1 state: