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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa

Z-1616-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
430 kits
Official record key
device-enforcement:Z-1616-2017

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: 029078C Exp Date 2017-10-26; 030847C Exp Date 2018-01-12; 030847C Exp Date 2018-03-21;

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field