Datascope Corporation Recall: MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Inserti
Datascope Corporation Recall: MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Inserti is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Datascope Corporation; Product: MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Ballo
| Recalling firm | Datascope Corporation |
|---|---|
| Product | MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA |
| Reason for recall | It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution. |
| Recall initiated | 20160513 |
| Recall number | Z-1935-2016 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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