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Recall Observatory FDA recall evidence

Device product

Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.

Z-2211-2015

February 11, 2015

Class II

Product summary

Firm
EXP Pharmaceutical Services Corp
Event
Event 71608
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2211-2015

Official wording

Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Code information: OEM Catalog number 408-800;

Distribution pattern: Distributed in DC and the states of CO, CA, FL, TX, and AR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.