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Recall Observatory FDA recall evidence

Device product

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

Z-0637-2018

January 22, 2018

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 79052
Status
Terminated
Classification
Class II
Quantity
181 units
Official record key
device-enforcement:Z-0637-2018

Official wording

Reason: 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.

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

Distribution pattern: US Distribution to: NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.