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Z-2798-2015 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

FDA device recall Z-2798-2015 was initiated by Resource Optimization & Innovation Llc on Aug 19, 2015 and is designated Class II. Reason for recall: Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. The recall status is terminated (terminated Apr 5, 2017). Affected quantity: 24 kits.

Recall Details

Product Type: Devices
Report Date: Sep 30, 2015
Initiation Date: Aug 19, 2015
Termination Date: Apr 5, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24 kits

Product Description

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

Reason for Recall

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

Distribution Pattern

Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.

Code Information

023735

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2798-2015
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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