Drug recall
NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL…
FDA recall event 77810 · Class II · Sorin Group USA, Inc.
Key facts
| Event ID | 77810 |
|---|---|
| Recall numbers | Z-2783-2017, Z-2784-2017, Z-2785-2017, Z-2786-2017, Z-2787-2017, Z-2788-2017, Z-2789-2017, Z-2790-2017, Z-2791-2017, Z-2792-2017, Z-2793-2017, Z-2794-2017 and 4 more |
| Recalling firm | Sorin Group USA, Inc. |
| Product type | Devices |
| Products | NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE, NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE, NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA, 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 and 11 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 29, 2017 |
| Report date | Aug 9, 2017 |
| Termination date | Apr 12, 2021 |
| City | Arvada |
| State | CO |
| Country | United States |
| FEI number | 1718850 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: