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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn

Z-1644-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
2016 kits
Official record key
device-enforcement:Z-1644-2017

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: 027525B Exp Date 2017-08-14; 028915B Exp Date 2017-10-19; 030195B Exp Date 2017-12-21; 031255B Exp Date 2018-01-29; 032688B Exp Date 2017-09-30; 033330B Exp Date 2018-05-03

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field