Skip to content
Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn

Z-1661-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
450 kits
Official record key
device-enforcement:Z-1661-2017

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: 030228A Exp Date 2017-12-23; 031467A Exp Date 2018-02-09; 032767A Exp Date 2018-04-07

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field