FDA-Device2018-02-28Class II
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
DeRoyal Industries Inc
Hazard
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.
Sold states
US Distribution to: NY
Affected count
181 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2018Don't want to check this manually?
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