Z-2189-2018 Class II Terminated
FDA device recall Z-2189-2018 was initiated by Angiodynamics Inc. (Navilyst Medical Inc.) on May 10, 2018 and is designated Class II. Reason for recall: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). The recall status is terminated (terminated May 13, 2020). Affected quantity: 50 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 20, 2018
- Initiation Date
- May 10, 2018
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 boxes
Product Description
Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
Reason for Recall
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Distribution Pattern
The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
Code Information
UPN: H965458180; Lot: 5303175, 5305572
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2189-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026