Recalls / —
—#165940
Product
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
- FDA product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K981035
- Affected lot / code info
- Lot numbers 3306404, 3314069, and 3318698.
Why it was recalled
The product was mislabeled with the incorrect label.
Root cause (FDA determination)
Labeling Change Control
Action the firm took
Recall notifications dated 7/13/2018 were issued via FedEx overnight mail on 7/13/2018 explaining the reason for recall, risk to health, and instructing the customer to check their inventory for the affected lot numbers.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Timeline
- Recall initiated
- 2018-07-13
- Terminated
- 2018-10-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165940. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.