medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Reported: October 20, 2021 Initiated: March 10, 2020 #Z-0092-2022
Product Description
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Reason for Recall
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 17980 units
- Distribution
- Austria, France, Germany, Great Britain, and Saudi Arabia
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1. Recalled by Smiths Medical ASD Inc.. Units affected: 17980 units.
Why was this product recalled? ▼
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0092-2022.
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