DeRoyal Industries Inc: DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

Hazard

DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.

Details from the source

Reason for recall: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach. Distribution: US Nationwide distribution in the states of IL, MO. Quantity: 157 packs Lot/code info: a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023

UPC codes

00749756903936, 00749756903931

Source

Official record: FDA (Device enforcement) ↗

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