Drug recall
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are…
FDA recall event 58185 · Class II · Terumo Cardiovascular Systems Corp
Key facts
| Event ID | 58185 |
|---|---|
| Recall numbers | Z-0156-2015, Z-0157-2015, Z-0158-2015, Z-0159-2015, Z-0160-2015, Z-0161-2015 |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Product type | Devices |
| Products | Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass…, Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient…, Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery…, Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the…, Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line, Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line., Defect in the luer connector can compromise the seal on the female side of the connector. and the… |
| Initiation date | Mar 1, 2011 |
| Report date | Nov 12, 2014 |
| Termination date | Nov 6, 2014 |
| City | Ashland |
| State | MA |
| Country | United States |
| FEI number | 1000149028 |
At a glance
- 1–9 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: