Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M 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 70 units of Inspire 8 Integrated Phisio OXY with HVR Reservoir sterile devices distributed to New Jersey, California, Minnesota, Missouri, and Massachusetts. The recalled products contain an incorrect expiration date format in the Unique Device Identification (UDI) barcode and readable code printed on the packaging. The expiration date appears in the format DDMMYY instead of the correct YYMMDD format, though the expiration date printed in the standard field on package labels is correct. The affected lots are 1709190230 with an expiration date of 09/17/2020 and 1710260210 with an expiration date of 10/24/2020.
The source document does not specify a remedy or corrective action for consumers who may have received affected units.
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: 70 Lot/code info: Lot:1709190230, UDI: (01)08033178112369(17)200917(10)1709190230, Exp: 09/17/2020; Lot: 1710260210, UDI: (01)08033178112369(17)201024(10)1710260210, Exp: 10/24/2020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.