Skip to content
Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills

Z-1591-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
456 kits
Official record key
device-enforcement:Z-1591-2017

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: 031066A Exp Date 2018-01-21; 031996A Exp Date 2018-03-02; 033021A Exp Date 2018-04-19

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field