Z-1946-2012Class II

Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695...

Name: Z-1946-2012 Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695...
Creator: Argon Medical Devices, Inc
Published: 2012-05-04
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2012-05-04 / Terminated / root cause: packaging

FDA source

Argon Medical Devices, Inc began a recall of 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... on 2012-05-04. FDA classified it as Class II and gives the reason as "Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1946-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-04
Posted: 2012-07-06
Terminated: 2013-01-14
Recalling firm: Argon Medical Devices, Inc
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.
Product code: DSK Computer, Blood-Pressure
Reason for recall: Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Root cause tag: packaging
FDA root cause: Packaging
Action: Argon Medical Devices sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Recall Response Form was attached to the letter for customers to complete and return to the firm via fax to 903-577-9393. Contact the firm at [email protected] for questions regarding this recall.
Quantity in commerce: 10 pieces
Distribution: Distributed only in Missouri.
Product codes and lots: Lot Number 204889, Expiration Date March 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1946-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code DSK

K885235Class IISafe-Draw(tm) Blood Sampling Reservoir & Access.Spectramed, Inc. / cleared 1989-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)