Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-1617-2017)

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: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa

Product Classification:

Class II

Date Initiated: January 9, 2017

Date Posted: April 5, 2017

Recall Number: Z-1617-2017

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: 42 kits

Code Information:

034203A Exp Date 2017-11-30; 036670A Exp Date 2017-11-30;

Distribution Pattern:

US Distribution to LA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated