Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW recall: Endotoxin
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
Why was Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW recalled?
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN: H965458820; Lot: 5301752
- Product
- Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Quantity
- 17 boxes
- Distribution
- 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.
- Recall date
- June 20, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)