LivaNova Inspire 6 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date
LivaNova USA is recalling 42 units of Inspire 6 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a documentation and labeling issue where the physical package label is correct, and the hazard is limited to a formatting error in the UDI barcode, fitting the criteria for cosmetic or documentation issues.
Plain-English summary
LivaNova USA is recalling 42 units of Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713. The recall involves Lot 1709190228, which has an expiration date of 09/17/2020. The devices were distributed to the states of New Jersey, California, Minnesota, Missouri, and Massachusetts.
The recall was initiated because some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) barcode and the readable code beneath it. Specifically, the expiration date is reported as DDMMYY instead of the standard YYMMDD format. The expiration date printed on the applicable field of the package labels is correct.
The INSPIRE 6M Hollow Fiber Oxygenator and INSPIRE HVR Hardshell Venous/Cardiotomy Reservoir are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. The oxygenator provides gas exchange support and blood temperature control, while the reservoir collects, de-foams, and filters venous blood. Both elements are intended for use for 6 hours or less.
The recalled product
- 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…
- Manufacturer
- LivaNova USA
- Hazard
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: 1709190228
- UDI: (01)08033178112352(17)200917(10)1709190228
- Exp: 09/17/2020
Distribution
Part of a larger recall action
This product is one of 2 recalled by LivaNova USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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