Stradis Medical Anesthesia Kit Recalled Due to Sterility Breach Risk
Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product (sterility breach in anesthesia kits) where no illnesses or injuries have been reported. The potential for compromise to sterile medical equipment warrants a High severity rating per the rubric.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Lum Lam Custom Pack Anesthesia Kits. The outer bag of affected kits may be perforated or torn, which could compromise the sterility of the kit.
The recall affects 21 units with lot numbers 21300478831 and 21314479685 (SKU/Part Number 570-2674; UDI H65257026741). The kits were distributed nationwide in Indiana, Texas, and Pennsylvania.
Healthcare facilities and providers who received these kits should verify their inventory against the lot numbers listed above. Facilities should consult with Stradis Medical regarding appropriate handling, return, or disposal of the affected anesthesia kits.
The recalled product
- Product
- Lum Lam Custom Pack - Anesthesia Kit
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- SKU/Part Number 570-2674
- UDI H65257026741 Lot Numbers: 21300478831 and 21314479685
Distribution
Distributed nationwide across the United States.
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