Recall Z-1946-2012— Argon Medical Devices, Inc

Name: FDA recall Z-1946-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-04

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2012-05-04, terminated 2013-01-14. It names one FDA 510(k) clearance: K885235. Product: Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.. Reason: Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-05-04
Terminated: 2013-01-14
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.Spectramed, Inc.·cleared 1989-01-25

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

Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.

Reason for recall

Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.

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