Recall Z-3196-2018 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Smiths Medical ASD Inc.
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.
| Date | Jul 13, 2018 |
| Status | Terminated |
| Reason | The product was mislabeled with the incorrect label. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 29,600 kits |
| Distribution | US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981035 | PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES Sims Portex, Inc., Apr 21, 1998 |