DeRoyal Industries Inc: Medical Device Recall in 2018 - (Recall #: Z-0637-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

Product Classification:

Class II

Date Initiated: January 22, 2018

Date Posted: February 28, 2018

Recall Number: Z-0637-2018

Event ID: 79052

Reason for Recall:

DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

Status: Terminated

Product Quantity: 181 units

Code Information:

Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903

Distribution Pattern:

US Distribution to: NY

Voluntary or Mandated:

Voluntary: Firm initiated