Reported Mar 21, 2018 · Terminated
INFINITY DUAL HEMO MCable Pod
Draegar Medical Systems, Inc.
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: Draegar Medical Systems, Inc. · 6 Tech Dr · Andover, MA · 01810-2434
Is this the product you have?
- INFINITY DUAL HEMO MCable Pod
- Lot codes and dates
- Have the affected revision indexes15 or 16 (found on the product label)
- Amount recalled
- 2,760
Why it was recalled
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
This product could cause temporary or reversible health problems — stop using it.
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