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Open, Classified

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

FDA Recall Z-1283-2023 · Posted 2023-03-23

Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeKDQ
Date Initiated2023-02-09
Product Quantity27,200 devices

Reason for Recall

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.

Firm Action

The firm issued an URGENT DEROYAL RECALL NOTICE its consignees by email and letter beginning on 02/09/2023. The notice explained the problem and risk, and requested the following actions be taken: Identify and quarantine any affected product found in inventory. If the product has been further distributed, please notify then of this recall. Firm is seeking product return. Questions about receiving credit for return merchandise, contact Jennifer Marsh at [email protected] or by phone 865-362-4203 or email us at [email protected]. If you have questions regarding this recall please contact us at 865-362-6465 or email us at [email protected].

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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