Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-1638-2017)

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: 800401001, Sterile, GS0470A - Lap PK - Spohn

Product Classification:

Class II

Date Initiated: January 9, 2017

Date Posted: April 5, 2017

Recall Number: Z-1638-2017

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: 5,000 kits

Code Information:

028131A Exp Date 2017-09-16; 028606A Exp Date 2017-10-13; 029244A Exp Date 2017-11-02; 029917A Exp Date 2017-12-08; 030686A Exp Date 2018-01-04; 031323A Exp Date 2018-02-01; 031824A Exp Date 2018-02-24; 032567A Exp Date 2018-03-31; 033054A Exp Date 2018-04-21; 033680A Exp Date 2018-05-19;

Distribution Pattern:

US Distribution to LA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated