Ethicon PERMA-HAND Silk Surgical Suture recalled for contaminating alcohol fluid
What this means
Ethicon surgical sutures were packaged with an alcohol-based fluid that was not part of the product design. If the fluid contacts the suture during surgery, it can weaken the suture's strength and knot security, potentially causing wound complications including bleeding or reopening.
- Check suture packages for any fluid before use.
- If fluid is present, do not use the suture and contact your supplier for a replacement.
- If sutures were already used in a procedure, consult your surgical team about monitoring the patient for wound complications.
- Report any adverse events to the FDA MedWatch program.
The agency's original wording
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2027More Ethicon recalls
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