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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn

Z-1548-201

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
2,122 kits
Official record key
device-enforcement:Z-1548-201

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: 029388C Exp Date: 2017-11-09; 030253C Exp Date: 2017-12-30; 032103C Exp Date: 2018-03-07; 033169C Exp Date: 2018-04-26; 034466C Exp Date: 2018-06-22;

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field