ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Argon Medical Devices, Inc. 1445 Fl
FDA device recall Z-1744-2010 · posted 2010-06-02 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
- Action taken
- Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm. For further information, contact Argon Medical Devices at 1-903-677-9375.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- KGC
- Quantity affected
- 10 kits
- Distribution
- Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.
- Date initiated
- 2010-03-29
- Date posted
- 2010-06-02
- Date terminated
- 2010-07-29
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTERIAL LINE KIT (K780871) | Argon Medical Corp. | 1978-06-14 |