FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0288-2020
- Recalling firm
- Argon Medical Devices, Inc
- Product
- (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.
- Status
- Terminated
- Initiated
- 2018-10-16
- Posted
- not on file
- Terminated
- 2021-06-15
- 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.
- Lot, serial or model codes
- (1) Double Female LL Adapter-special adapter to convert male fitting to a female luer lock - Lot numbers 11228606, 11227966, 11226655; and (2) Double Male LL Adapter-special adapter to convert a female fitting to a male luer lock - Lot numbers 11227508, 11229885, 11230268, and 11231393.
- 510(k) numbers
- ["K810637"]
- PMA numbers
- not on file
- Product code
- DRS
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28