FDA Recall
Terminated
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Recall: Z-0289-2020
·
Initiated October 16, 2018
Recall
- Recall Number
- Z-0289-2020
- Event Number
- 83633
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- DRS
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- October 16, 2018
- Terminated
- June 15, 2021
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
Description
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Reason
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Action
The recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.
Distribution
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Quantity
Total number in recall for all products in dist: 49,130 units