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

FDA device recall Z-1283-2023 · posted 2023-03-23 · Open, Classified

Recall details

Recalling firm

DeRoyal Industries Inc

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.

Action taken

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 jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com. If you have questions regarding this recall please contact us at 865-362-6465 or email us at recalls@deroyal.com.

Root cause

Process control

Status

Open, Classified

Product code

KDQ

Quantity affected

27,200 devices

Distribution

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

Date initiated

2023-02-09

Date posted

2023-03-23

Location

Powell, TN