Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-1548-201)

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: 800407003, Sterile, OR0476C - Ortho Pk - Spohn

Product Classification:

Class II

Date Initiated: January 9, 2017

Date Posted: April 5, 2017

Recall Number: Z-1548-201

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: 2,122 kits

Code Information:

029388C Exp Date: 2017-11-09; 030253C Exp Date: 2017-12-30; 032103C Exp Date: 2018-03-07; 033169C Exp Date: 2018-04-26; 034466C Exp Date: 2018-06-22;

Distribution Pattern:

US Distribution to LA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated