FDA Device recall Z-2768-2017
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmona…
- FDA Device
- Class II
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class II recall of DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmona… 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-2768-2017 |
| 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 Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
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. 61000: Product UPN: 20613994846604: Lot No. 2016020865, 2016030859, 2016031538, 2016040539, 2016040859,…Model No. 61000: Product UPN: 20613994846604: Lot No. 2016020865, 2016030859, 2016031538, 2016040539, 2016040859, 2016050268, 2016050556, 2016051179, 201605C063, 201605C064, 201605C065, 201605C066, 201605C067, 201605C068, 201605C069, 2016060275, 2016060525, 2016060896, 2016060897, 2016061082, 2016061083, 2016061084, 2016061476, 2016061477, 2016061478, 2016061479, 2016061480, 2016070727, 2016070744, 2016070753, 2016070962, 2016070963, 201607C046, 201607C047, 2016080349, 2016081585, 2016081586, 2016081587, 2016090237, 2016090593, 2016090594, 2016091409, 2016091410, 2016100571, 2016100572, 2016100875, 2016100876, 2016110851, 2016110852, 2016111130, 2016111131, 2016111132, 2016111133, 2016120836, 201612C037, 2017010052, 2017020120, 2017020122, 2017021065, 2017021066, 2017030114, 2017030115, 2017030116, 2017030117, 2017030118, 2017030119, 2017030595, 2017030951, 2017031135, 201703C055. Model 62000: Product UPN: 2061399484 |
|---|
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-2768-2017%22
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