Ethicon, Inc. is recalling 16,524 units of MONOCRYL (poliglecaprone 25) Sutures (Product Number Y936H) because of a manufacturing mix-up. Affected packages may contain the wrong needle type or size and an incorrect suture length. These sutures are used for general soft tissue repair but are not intended for use in the brain, heart, or eyes. No injuries have been reported, and the manufacturer initiated the recall after discovering the component error. If you have these products, you should stop using them and contact the manufacturer or your supplier for a replacement.
Using the wrong size needle or suture during a procedure can lead to surgical delays, improper tissue closure, or the need for additional medical procedures. No incidents or injuries have been reported in connection with this defect.
Indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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