INFINITY DUAL HEMO MCable Pod
Reported: March 21, 2018 Initiated: October 4, 2017 #Z-0942-2018
Product Description
INFINITY DUAL HEMO MCable Pod
Reason for Recall
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.
Details
- Recalling Firm
- Draegar Medical Systems, Inc.
- Units Affected
- 2,760
- Distribution
- Nationally
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
INFINITY DUAL HEMO MCable Pod. Recalled by Draegar Medical Systems, Inc.. Units affected: 2,760.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-0942-2018.
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