Recall Z-1283-2023
DeRoyal Industries Inc · initiated February 9, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Codes / lots: GTIN 50749756377046, Lot 58447585 exp. 12/22/2027
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1283-2023
- Initiated
- February 9, 2023
- Posted by FDA
- March 23, 2023
- Product code
- KDQ – Bottle, Collection, Vacuum
- Quantity
- 27,200 devices
- Distribution
- US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
- Recalling firm
- DeRoyal Industries Inc, Powell, TN