Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-1634-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa

Product Classification:

Class II

Date Initiated: January 9, 2017

Date Posted: April 5, 2017

Recall Number: Z-1634-2017

Event ID: 76255

Reason for Recall:

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.

Status: Terminated

Product Quantity: 25 kits

Code Information:

038092C Exp Date 2018-07-30; 039713C Exp Date 2018-08-30;

Distribution Pattern:

US Distribution to LA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated