FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: 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.
- Recall number
- Z-1946-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-05-04
- Posted
- 2012-07-06
- Terminated
- 2013-01-14
- Reason
- Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
- 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 CRS@argonmedical.com for questions regarding this recall.
- Quantity
- 10 pieces
- Distribution
- Distributed only in Missouri.
- Lot, serial or model codes
- Lot Number 204889, Expiration Date March 2017
- 510(k) numbers
- ["K885235"]
- PMA numbers
- not on file
- Product code
- DSK
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28