Z-0290-2020Class II
(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile...
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 Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way... 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-0290-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Argon Medical Devices, Inc
- Product
- (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 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) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A-Lot numbers 11226656 and 11228887; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A - Lot numbers 11226187, 11229619, and 11227967; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A - Lot numbers 11228888, 11230598; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A - Lot number 11228245; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A - Lot number 11232206; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590 - Lot numbers 11229800 and 11232485.
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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.