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Recall Observatory FDA recall evidence

Device product

Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

Z-2193-2018

May 10, 2018

Class II

Product summary

Firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Event
Event 80169
Status
Terminated
Classification
Class II
Quantity
58 boxes
Official record key
device-enforcement:Z-2193-2018

Official wording

Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Code information: UPN: H965458860; Lot: 5303442

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).