Medtronic Perfusion Systems: DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended f

Is my product affected?

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 hour

• UPC 20613994900412

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

What happened

Medtronic recalled DLP Cardioplegia Adapters with Pressure Ports used in perfusion systems because small pinholes were identified in the sterile packaging of a single pouch configuration. The recall affected seven different products across 63,053 units distributed worldwide, including throughout the United States and 33 other countries. The affected devices were manufactured under Model No. 15004 with specific lot numbers ranging from 2016031072 through 2017040113.

The source document does not specify what consumers or healthcare facilities should do regarding this recall.

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. 15004; Product UPN 20613994900412; Lot No. 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, 2017040113.

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery2017-06-22
• 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 cannulae2017-06-22
• 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