Z-0637-2018 Class II Terminated
FDA device recall Z-0637-2018 was initiated by DeRoyal Industries Inc on Jan 22, 2018 and is designated Class II. 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. The recall status is terminated (terminated Aug 19, 2020). Affected quantity: 181 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 28, 2018
- Initiation Date
- Jan 22, 2018
- Termination Date
- Aug 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 181 units
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
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.
Distribution Pattern
US Distribution to: NY
Code Information
Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0637-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026