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Recall Observatory FDA recall evidence

Device product

AMS 4675 Angio Pack. For use in a general clinical procedure.

Z-0377-2016

November 02, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 72604
Status
Terminated
Classification
Class II
Quantity
40 kits
Official record key
device-enforcement:Z-0377-2016

Official wording

Reason: AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

Code information: Lot 84371, expiration date: 2/28/2017

Distribution pattern: Distributed in AL and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.