DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde f

FDA device recall Z-2765-2017 · posted 2017-07-10 · Terminated

Recall details

Recalling firm

Medtronic Perfusion Systems

Reason for recall

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

Action taken

Medtronic sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected consignees, both in the US, via 2-Day UPS Mail, and OUS, via local methods. Consignees were asked to quarantine and return any affected product. No recommendations were made for patients who have undergone procedures using affected product. US consignees were asked to complete and return a recall notification confirmation certificate to fax 651-367-0612, indicating that they were informed of the recall and executed the appropriate action. Customers with questions were instructed to contact Customer Service at 1-800-854-3570. For questions regarding this recall call 763-526-2494.

Root cause

Packaging process control

Status

Terminated

Product code

DTL

Quantity affected

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, Ja

Date initiated

2017-06-22

Date posted

2017-07-10

Date terminated

2020-07-22

Location

Brooklyn Park, MN

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