Argon Medical Devices, Inc: Medical Device Recall in 2012 - (Recall #: Z-1946-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 4, 2012

Date Posted: July 18, 2012

Recall Number: Z-1946-2012

Event ID: 61832

Reason for Recall:

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

Status: Terminated

Product Quantity: 10 pieces

Code Information:

Lot Number 204889, Expiration Date March 2017

Distribution Pattern:

Distributed only in Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated