Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-1620-2017)

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: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa

Product Classification:

Class II

Date Initiated: January 9, 2017
Date Posted: April 5, 2017
Recall Number: Z-1620-2017
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: 120 kits
Code Information:

037945B Exp Date 2018-09-06; 039741B Exp Date 2018-11-21;

Distribution Pattern:

US Distribution to LA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated