FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
- Recall number
- Z-0092-2022
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
- Status
- Terminated
- Initiated
- 2020-03-10
- Posted
- not on file
- Terminated
- 2023-09-22
- Reason
- Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- Root cause
- Component design/selection
- Action
- The firm initiated the recall by letter during the week of 03/10/2020. The notices requested the direct consignee notify their customers and collect the responses. The firm is seeking return of the products.
- Quantity
- 17980 units
- Distribution
- Austria, France, Germany, Great Britain, and Saudi Arabia
- Lot, serial or model codes
- All codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DRO
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28