Medtronic Perfusion Systems: DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

Is my product affected?

DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

• UPC 20613994918554

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

What happened

Medtronic recalled approximately 63,053 DLP Extension Line Adapters (20 inches in length) used during heart bypass surgery due to small pinholes discovered in sterile packaging pouches. The affected products were distributed worldwide, including throughout the United States and 32 other countries. Seven different products were impacted, with lot numbers ranging from 2016020769 through 2017030506.

The recall affected 48,180 units in the US and 14,873 units outside the United States. The source document does not specify a remedy or recommended action for affected consumers.

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. 11001G; Product UPN 20613994918554; Lot No. 2016020769, 2016030796, 2016040778, 2016060872, 2016061425, 2016070500, 2016081190, 2016090516, 2016091016, 2016110504, 2016120414, 2017010236, 2017011281, 2017030506.

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• 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 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