Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-1659-2017)

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: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn

Product Classification:

Class II

Date Initiated: January 9, 2017

Date Posted: April 5, 2017

Recall Number: Z-1659-2017

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: 148 kits

Code Information:

029296B Exp Date 2017-11-04; 030567B Exp Date 2017-12-29; 031350B Exp Date 2018-02-03; 033935B Exp Date 2017-06-30

Distribution Pattern:

US Distribution to LA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated