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Recall Observatory FDA recall evidence

Device product

DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

Z-1283-2023

February 09, 2023

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91760
Status
Ongoing
Classification
Class II
Quantity
27,200 devices
Official record key
device-enforcement:Z-1283-2023

Official wording

Reason: The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.

Code information: GTIN 50749756377046, Lot 58447585 exp. 12/22/2027

Distribution pattern: US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.