Z-0863-2022 Class II Ongoing
FDA device recall Z-0863-2022 was initiated by Stradis Medical, LLC Dba Stradis Healthcare on Feb 25, 2022 and is designated Class II. Reason for recall: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. The recall status is ongoing. Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Feb 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
Lum Lam Custom Pack - Anesthesia Kit
Reason for Recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Distribution Pattern
US Nationwide distribution in the states of IN, TX, and PA.
Code Information
SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0863-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026