Recall Z-1716-2020— Smiths Medical ASD, Inc.

Name: FDA recall Z-1716-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-07

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2020-01-07, terminated 2020-12-14. It names one FDA 510(k) clearance: K952516. Product: Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes. Reason: Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-07
Terminated: 2020-12-14
Firm location: Keene, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K952516 — PRO-VENT, LINE DRAW, PULSATORSmiths Industries Medical Systems, Inc.·cleared 1995-07-14

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 ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

Reason for recall

Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

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