Reported Aug 2, 2017 · Terminated
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the…
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 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 hours
- Lot codes and dates
Model No. 15004Product UPN 20613994900412Lot No. 20160310722016031509201605024320160812192016100630201612008320161204482017040113
- 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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