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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn

Z-1646-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
274 kits
Official record key
device-enforcement:Z-1646-2017

Official wording

Reason: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information: 029922D Exp Date 2017-10-30; 031037D Exp Date 2017-12-30; 032865D Exp Date 2018-3-30

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field