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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn

Z-1657-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
216 kits
Official record key
device-enforcement:Z-1657-2017

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: 026440A Exp Date 2017-07-16; 030021A Exp Date 2017-12-11; 030186A Exp Date 2017-12-21; 031464A Exp Date 2018-02-15; 032390A Exp Date 2018-03-22; 033782A Exp Date 2018-05-20

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field