Z-0288-2020Class II
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL...
Argon Medical Devices, Inc / initiated 2018-10-16 / Terminated / root cause: manufacturing process
Argon Medical Devices, Inc began a recall of (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... on . FDA classified it as Class II and gives the reason as "The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0288-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- 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.
- Product code
- DRS Transducer, Blood-Pressure, Extravascular
- Reason for recall
- 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 tag
- manufacturing process
- FDA 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 in commerce
- 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.
- Product codes and lots
- (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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0288-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0289-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0290-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0291-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0292-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0293-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0294-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0295-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0296-2020 | Class II | Terminated | Voluntary: Firm initiated |
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