Medtronic Perfusion Systems: DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

Is my product affected?

DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

• UPC 20613994918608
• UPC 20613994918585

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

What happened

Medtronic recalled DLP Pressure Monitoring Extension Line Adapters used during heart bypass surgery due to small pinholes found in the sterile packaging of certain units. The recall affected approximately 63,053 units worldwide, including 48,180 in the United States, distributed across numerous countries. Two models were involved: Model No. 25009 and Model No. 25010, with specific lot numbers ranging from 2016 through 2017.

The affected products were identified by model number, UPN (Universal Product Number), and lot number. The source does not specify a remedy or what action 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. 25009; Product UPN 20613994918608; Lot No. 2016090217, 2016091068, 2016100893, 2016110439, 2016120464, 2017010278, 2017030102, 2017030576, 2017031125. Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841, 2016031522, 2016050255, 2016070494, 2016081243, 2016090923, 2016110054, 2016110837, 2017040714.

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 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 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