Recall Z-1283-2023 ยท KDQ Bottle, Collection, Vacuum
DeRoyal Industries Inc
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
| Date | Mar 23, 2023 (initiated Feb 9, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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 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 |
| Quantity | 27,200 devices |
| Distribution | US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.