Recall Z-1738-2010 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Argon Medical Devices, Inc
CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx.. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
| Date | Jun 2, 2010 (initiated Mar 29, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Package design/selection |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781333 | CENTRAL CATHETER TRAY Argon Medical Corp., Oct 24, 1978 |