LivaNova Recalls Sorin Group Smart Perfusion Packs Due to Incorrect Expiration Date
LivaNova USA is recalling 16 units of Sorin Group Smart Perfusion Pack E-Packs because they are labeled with incorrect expiration dates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a labeling error regarding expiration dates.
Plain-English summary
LivaNova USA is recalling 16 units of the Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L. The affected units are single-use, sterile, prescription medical devices. The recall involves 6 units from lot 1717800062 and 10 units from lot 1720800071.
The recall was initiated because the products are labeled with the incorrect expiration date. This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Distribution was made to one consignee in Los Angeles. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
- Manufacturer
- LivaNova USA
- Hazard
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 (4)
- Lot 1717800062
- UDI (01)00803622108075(240)088511400(17)190630(10)1717800082
- and Lot 1720800071
- UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Distribution
Distributed in 1 state:
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