FDA Device recall Z-2765-2017
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion
- FDA Device
- Class II
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class II recall of DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion by Medtronic Perfusion Systems, citing identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2765-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-22 |
| Published | 2017-08-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
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 direct connections to the cannulae
Reason
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Identifiers
| code_info | Model No. 13001; Product UPN 20613994677611; Lot No. 2016020795, 2016030222, 2016030813, 2016031019, 2016040411, 201604…Model No. 13001; Product UPN 20613994677611; Lot No. 2016020795, 2016030222, 2016030813, 2016031019, 2016040411, 2016040614, 201604C004, 2016050516, 2016050769, 2016051176, 2016060227, 2016061042, 2016061440, 2016070193, 2016070921, 2016070922, 2016080373, 2016090545, 2016091365, 2016100614, 2016101189, 2016101190, 2016110125, 2016110825, 2016111024, 2016111026, 201612C046, 2017010914, 2017010915, 2017020855, 2017020856, 2017021022, 201702C012, 2017030536, 2017031116, 2017040101. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2765-2017%22
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