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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis

Z-1677-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
670 kits
Official record key
device-enforcement:Z-1677-2017

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: 026385D Exp Date 2017-07-13; 028105D Exp Date 2017-09-14; 029774D Exp Date 2017-12-04; 031980D Exp Date 2018-03-02; 033476D Exp Date 2018-05-10

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field