Recalls / —
—#189424
Product
smiths medical portex Loss of Resistance Device, REF 100/398/000
- FDA product code
- BSP — Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K172410
- Affected lot / code info
- Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
Why it was recalled
The labeling was missing information on sterilization and prohibition of reuse.
Root cause (FDA determination)
Error in labeling
Action the firm took
The firm notified their consignees of the recall by email on 12/08/2021. Distributors were directed to notify their consignees. The firm is seeking return of the product.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
Timeline
- Recall initiated
- 2020-12-08
- Terminated
- 2023-08-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.