CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
AHD Luer Lock Cap recalled by Argon Medical Devices
Argon Medical Devices is recalling Argon Medical Devices AHD Luer Lock Cap, distributed nationwide in the US. The recall was initiated on 16 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0296-2020
- FDA event ID
- 83633
- Recalling firm
- Argon Medical Devices, Athens, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2018
- FDA classified
- 5 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Oct 2018 | Recall initiated by company | |
| 5 Nov 2019 | Classified by FDA | +385 days |
| 13 Nov 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Where it was distributed
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Questions about this recall
Is AHD Luer Lock Cap recalled?
Yes. Argon Medical Devices recalled AHD Luer Lock Cap on 16 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0296-2020.
Why was it recalled?
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Which lots are affected?
Lot numbers 11228902 and 11230445
Where was it sold?
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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