—#198808

Product

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

FDA product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: GTIN 50749756377046, Lot 58447585 exp. 12/22/2027

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

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

Timeline

Recall initiated: 2023-02-09
Posted by FDA: 2023-03-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198808. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.