CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Lum Lam Custom Pack - Anesthesia Kit recalled by Stradis Medical
Stradis Medical is recalling Lum Lam Custom Pack - Anesthesia Kit, distributed nationwide in the US. The recall was initiated on 25 Feb 2022 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-0863-2022
- FDA event ID
- 89671
- Recalling firm
- Stradis Medical, Peachtree Corners, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2022
- FDA classified
- 4 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2022 | Recall initiated by company | |
| 4 Apr 2022 | Classified by FDA | +38 days |
| 13 Apr 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
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
Lum Lam Custom Pack - Anesthesia Kit
Where it was distributed
US Nationwide distribution in the states of IN, TX, and PA.
Questions about this recall
Is Lum Lam Custom Pack - Anesthesia Kit recalled?
Yes. Stradis Medical recalled Lum Lam Custom Pack - Anesthesia Kit on 25 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-0863-2022.
Why was it recalled?
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Which lots are affected?
SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685
Where was it sold?
US Nationwide distribution in the states of IN, TX, and PA.
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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