Reported Aug 2, 2017 · Terminated
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde…
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- 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 cannulae
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 13001— — 20613994677611Product UPN 20613994677611 — Lot No. 2016020795, 2016030222, 2016030813, 2016031019, 2016040411, 2016040614, 201604C004, 2016050516, 2016050769, 2016051176, 2016060227, 2016061042, 2016061440, 2016070193, 2016070921, 2016070922, 2016080373, 2016090545, 2016091365, 2016100614, 2016101189, 2016101190, 2016110125, 2016110825, 2016111024, 2016111026, 201612C046, 2017010914, 2017010915, 2017020855, 2017020856, 2017021022, 201702C012, 2017030536, 2017031116, 2017040101. - Amount recalled
- 63053 (48180 US) (14873 OUS)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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