Recall Z-3196-2018— Smiths Medical ASD Inc.

Name: FDA recall Z-3196-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-13

Class III · Terminated

Class III FDA medical device recall by Smiths Medical ASD Inc., initiated 2018-07-13, terminated 2018-10-19. It names one FDA 510(k) clearance: K981035. 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.. Reason: The product was mislabeled with the incorrect label..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class III
Status: Terminated
Initiated: 2018-07-13
Terminated: 2018-10-19
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K981035 — PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGESSims Portex, Inc.·cleared 1998-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The product was mislabeled with the incorrect label.

Data sourced from openFDA. This site is unofficial and independent of the FDA.