Skip to content
Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU

Z-1574-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
704 kits
Official record key
device-enforcement:Z-1574-2017

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: 026598A Exp Date 2017-06-30; 028130A Exp Date 2017-07-30; 028918A Exp Date 2017-01-30; 029122A Exp Date 2017-09-30; 029906A Exp Date 2017-10-30; 031960A Exp Date 2018-01-30; 033019A Exp Date 2018-04-30;

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field