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Recall Observatory FDA recall evidence

Device product

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

Z-2764-2017

June 22, 2017

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 77641
Status
Terminated
Classification
Class II
Quantity
63053 (48180 US) (14873 OUS)
Official record key
device-enforcement:Z-2764-2017

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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