Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical
FDA device recall Z-1946-2012 · posted 2012-07-06 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DSK
- Quantity affected
- 10 pieces
- Distribution
- Distributed only in Missouri.
- Date initiated
- 2012-05-04
- Date posted
- 2012-07-06
- Date terminated
- 2013-01-14
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (K885235) | Spectramed, Inc. | 1989-01-25 |