Recall Z-2252-2017 ยท GDR Saw, Manual And Accessories
Argon Medical Devices, Inc
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
| Date | May 11, 2017 |
| Status | Terminated |
| Reason | Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch. |
| Root cause | Process design |
| Action | Argon Medical Devices, Inc. is sending an Urgent Medical Device Recall letter by registered mail to the affected customer/hospital/distributor. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form. |
| Quantity | 7140 pieces |
| Distribution | Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.