The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1919-2018·Announced 2018-05-30

LivaNova Inspire 8 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

LivaNova USA is recalling 70 units of Inspire 8 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (incorrect date format in UDI) where the primary package label is correct, fitting the 'Minor labeling errors' criterion.

Plain-English summary

LivaNova USA is recalling 70 units of Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714. The recall involves specific lots: 1709190230 (expiration 09/17/2020) and 1710260210 (expiration 10/24/2020). These devices are intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass.

The recall is due to a labeling error where the expiration date printed in the Unique Device Identification (UDI) barcode and the readable code beneath it is formatted as DDMMYY instead of the standard YYMMDD. The expiration date printed on the applicable field of the package labels is correct. The affected units were distributed to the states of New Jersey, California, Minnesota, Missouri, and Massachusetts.

Healthcare facilities and consumers should stop using the affected devices and contact LivaNova USA for further instructions. This is a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

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…
Manufacturer
LivaNova USA
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
70

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 (6)

  • 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

Distribution

Distributed in 5 states:

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 →

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