Drug recall
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or…
FDA recall event 77641 · Class II · Medtronic Perfusion Systems
Key facts
| Event ID | 77641 |
|---|---|
| Recall numbers | Z-2764-2017, Z-2765-2017, Z-2766-2017, Z-2767-2017, Z-2768-2017 |
| Recalling firm | Medtronic Perfusion Systems |
| Product type | Devices |
| Products | DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate…, DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with…, DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery, DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery., DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. |
| Initiation date | Jun 22, 2017 |
| Report date | Aug 2, 2017 |
| Termination date | Jul 22, 2020 |
| City | Brooklyn Park |
| State | MN |
| Country | United States |
| FEI number | 1000116158 |
At a glance
- 1–9 Products in this recall
- 10–99 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: