Ethicon, Inc.: PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growt

Hazard

knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

Details from the source

Reason for recall: knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage Distribution: International (OUS) only: Canada, Japan, Australia and New Zealand Quantity: 7,560 eaches Lot/code info: UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027

UPC codes

10705031060623, 30705031060634

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.