FDA Medical Device Recalls (openFDA)
LivaNova USA: 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.
- Recall number
- Z-0664-2018
- Recalling firm
- LivaNova USA
- 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.
- Status
- Terminated
- Initiated
- 2017-12-19
- Posted
- not on file
- Terminated
- 2020-08-11
- Reason
- The product is labeled with the incorrect expiration date.
- Root cause
- Process control
- Action
- The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.
- Quantity
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
- Distribution
- Distribution was made to one consignee in LA.
- Lot, serial or model codes
- Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
- 510(k) numbers
- ["K981613"]
- PMA numbers
- not on file
- Product code
- DWE
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28