Recall Z-1115-2022— Radiometer Medical ApS

Name: FDA recall Z-1115-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-08

Class II · Ongoing

Class II FDA medical device recall by Radiometer Medical ApS, initiated 2022-04-08. It names one FDA 510(k) clearance: K962158. Product: Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE. Reason: Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product..

Recalling firm: Radiometer Medical ApS
Classification: Class II
Status: Ongoing
Initiated: 2022-04-08
Firm location: Bronshoj, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K962158 — PICO MODELS 30, 50, 70Radiometer America, Inc.·cleared 1996-10-29

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

Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE

Reason for recall

Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.

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