Skip to content
Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn

Z-1648-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
1056 kits
Official record key
device-enforcement:Z-1648-2017

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: 027522B Exp Date 2017-03-30; 030020B Exp Date 2017-10-30; 031641B Exp Date 2017-12-30; 033142B Exp Date 2017-12-30; 034112B Exp Date 2018-04-30

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field