Recall Z-0288-2020 ยท DRS Transducer, Blood-Pressure, Extravascular
Argon Medical Devices, Inc
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.
| Date | Oct 16, 2018 |
| Status | Terminated |
| Reason | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. |
| Root cause | Equipment maintenance |
| 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. |
| Quantity | Total number in recall for all products in dist: 49,130 units |
| Distribution | Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810637 | COBE DISPOSABLE PRESSURE TRANSDUCER Cobe Laboratories, Inc., Apr 23, 1981 |