Medtronic Perfusion Systems: DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standa

Is my product affected?

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

• UPC 20613994677611

Check against the official notice below — it lists the full affected range.

What happened

Medtronic has recalled its Perfusion Systems DLP Antegrade/Retrograde Adapter Method, a device used to deliver cardioplegia (heart protection solution) during cardiac surgery. The recall affects approximately 63,053 units worldwide, including 48,180 in the US and 14,873 internationally across more than 30 countries. Small pinholes were identified in the sterile packaging of these devices, which could potentially compromise sterility.

The affected products include multiple lot numbers of Model No. 13001 (Product UPN 20613994677611) manufactured between February 2016 and March 2017. The recall source does not specify what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Details from the source

Reason for recall: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. Distribution: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom. Quantity: 63053 (48180 US) (14873 OUS) Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• 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 the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hour2017-06-22
• DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.2017-06-22
• DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.2017-06-22
• FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in al2017-06-15

All FDA (Device enforcement) recalls