FDA Device recall Z-1919-2018
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the o…
- FDA Device
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the o… by Livanova Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1919-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-13 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Livanova Usa |
| Distribution | CA, MA, MN, MO, NJ |
Product
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 requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less.
Reason
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.
Identifiers
| code_info | Lot:1709190230, UDI: (01)08033178112369(17)200917(10)1709190230, Exp: 09/17/2020; Lot: 1710260210, UDI: (01)08033178112…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1919-2018%22
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