Skip to content
Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn

Z-1638-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
5,000 kits
Official record key
device-enforcement:Z-1638-2017

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: 028131A Exp Date 2017-09-16; 028606A Exp Date 2017-10-13; 029244A Exp Date 2017-11-02; 029917A Exp Date 2017-12-08; 030686A Exp Date 2018-01-04; 031323A Exp Date 2018-02-01; 031824A Exp Date 2018-02-24; 032567A Exp Date 2018-03-31; 033054A Exp Date 2018-04-21; 033680A Exp Date 2018-05-19;

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field