Recalls / —
—#189229
Product
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
- FDA product code
- DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- All codes
Why it was recalled
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Root cause (FDA determination)
Component design/selection
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Austria, France, Germany, Great Britain, and Saudi Arabia
Timeline
- Recall initiated
- 2020-03-10
- Terminated
- 2023-09-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.