Recall Z-1918-2018
LivaNova USA · initiated March 13, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M 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
Codes / lots: Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020
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.
FDA-determined cause: Incorrect or no expiration date
Action taken
On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.
Details
- Recall number
- Z-1918-2018
- Initiated
- March 13, 2018
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Quantity
- 42
- Distribution
- US Distribution to the states of : NJ, CA, MN, MO, MA
- Recalling firm
- LivaNova USA, Arvada, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1919-2018 Class II | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The…Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique… | 03/13/2018Terminated |