Ethicon Recalls Monocryl Sutures Due to Component Mix-Up
Ethicon, Inc. is recalling 16,524 units of Monocryl sutures because a manufacturing error may result in incorrect needle types, sizes, or suture lengths.
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 with a risk of harm due to incorrect specifications, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Ethicon, Inc. is recalling 16,524 units of MONOCRYL (poliglecaprone 25) Sutures, Reference Y936H, Lot Number TMMDQD. The recall is due to a component mix-up during manufacturing that may cause the affected products to contain incorrect needle types, sizes, or suture lengths.
The affected products were distributed to 43 states in the United States. The source text does not specify the number of reported injuries or illnesses associated with this recall.
Healthcare providers and facilities should stop using the affected sutures and contact Ethicon, Inc. for further instructions on how to return the products.
The recalled product
- Product
- MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
- Manufacturer
- ETHICON, INC.
- Hazard
- Affected units
- 16,524
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 (1)
- Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD
Distribution
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