Z-0637-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- January 22, 2018
- Termination Date
- August 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