Recalls / —
—#189408
Product
CADD Administration Sets, Model #21-7346-24
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K031361
- Affected lot / code info
- Lot Numbers: 3750848, 3776357, 3793886, 3766764, 3793887, 3796141, 3776356, 3793888, 3847669
Why it was recalled
Product may have been manufactured with an air filter assembled in an incorrect orientation.
Root cause (FDA determination)
Process control
Action the firm took
The firm notified its consignees of the issue beginning on 07/14/2020. The firm requested the return of unused product. Distributors were directed to notify their customers. For questions contact Smiths Medical via email at fieldactions@smiths-medical.com.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Canada
Timeline
- Recall initiated
- 2020-07-14
- Terminated
- 2023-08-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.