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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis

Z-1554-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
320 kits
Official record key
device-enforcement:Z-1554-2017

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: 037143E Exp Date 2018-08-05; 038259E Exp Date 2018-09-19; 040326E Exp Date 2018-12-14;

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field