Skip to content
Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo

Z-1630-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
236 kits
Official record key
device-enforcement:Z-1630-2017

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: 026403B Exp Date 2017-07-13; 029909B Exp Date 2017-12-08; 031012B Exp Date 2018-01-18; 031963B Exp Date 2018-03-01;

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field

Field note

Send feedback

We'll only use this to respond to your feedback.