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Recall Observatory FDA recall evidence

Device product

Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

Z-2234-2015

February 11, 2015

Class II

Product summary

Firm
EXP Pharmaceutical Services Corp
Event
Event 71608
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2234-2015

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 9-AVP2-012.

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.