SORIN GROUP — Class II medical device recall Z-2788-2017
Terminated recall by Sorin Group USA, Inc., reported 2017-08-09, distributed nationwide. Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches wh
| Recall number | Z-2788-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2017-06-29 |
| Classified | 2017-07-29 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2021-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 733 units |
| Reason classes | sterility |
| Lot numbers | 1619500015, 1620300020, 1623000025, 1623700026, 1624400017, 1625100125, 1626500068, 1627900033, 1628600023, 1629400030, 1632800035, 1634200023, 1634900050, 1635600025, 1700300019, 1700500032, 1702300048, 1703100033, 1703200053, 1703200057, 1703900069, 1705400037, 1707900050, 1708200042, 1710200084, 1713700057, 1715900028 |
| Model numbers | 044011200, 044042600 |
Product
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
Reason for recall
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2788-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.