FDAClass IIAugust 2, 2017

DLP Extension Line Adapters 20 in length Used to extend recall

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

Why was DLP Extension Line Adapters 20 in length Used to extend recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Recalling firm
Medtronic Perfusion Systems
Quantity
63053 (48180 US) (14873 OUS)
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.
Recall date
August 2, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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