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Recall Observatory FDA recall evidence

Device product

NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005

Z-1853-2017

January 13, 2017

Class II

Product summary

Firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Event
Event 76347
Status
Terminated
Classification
Class II
Quantity
8 boxes/25 units
Official record key
device-enforcement:Z-1853-2017

Official wording

Reason: The product has the potential to be non-sterile as it was not packaged in accordance to specification.

Code information: Lot Number: 5122528

Distribution pattern: CA, KY, MD, OR, VA, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product has the potential to be non-sterile as it was not packaged in accordance to specification.