Ethicon, Inc.: PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric ca

Hazard

Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

Details from the source

Reason for recall: Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved Distribution: International distribution in the countries of United Kingdom, Ireland and Turkey. Quantity: 1,656 eaches (OUS only) Lot/code info: UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH

UPC codes

10705031124691, 30705031124695

Source

Official record: FDA (Device enforcement) ↗

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