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.
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 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
- Hazard
- 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:
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