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 Recall Z-3196-2018 · Posted None
Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2018-07-13
Date Terminated2018-10-19
Product Quantity29,600 kits
Reason for Recall
The product was mislabeled with the incorrect label.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.