Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures r
Check against the official notice below — it lists the full affected range.
LivaNova USA is recalling 42 units of Inspire 6 Integrated Physio OXY with HVR Reservoir (Catalog # 050713) distributed to New Jersey, California, Minnesota, Missouri, and Massachusetts. The recalled products, identified by Lot 1709190228, contain an incorrect expiration date format in the Unique Device Identification (UDI) bar code and readable code printed on the packaging. The expiration date appears as DDMMYY instead of the correct YYMMDD format, though the expiration date printed in the main field on the package labels is correct.
The actual expiration date for the affected devices is September 17, 2020. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.
Reason for recall: Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed. Distribution: US Distribution to the states of : NJ, CA, MN, MO, MA Quantity: 42 Lot/code info: Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.