DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B recallZ-1283-2023 · DeRoyal Industries Inc · initiated Feb 9, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-1283-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 9, 2023
- Posted by the FDA
- Mar 23, 2023
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 27,200 devices
- Product code
- KDQ
- Distribution
- US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
Product description
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Code information (models, lots, serial numbers)
GTIN 50749756377046, Lot 58447585 exp. 12/22/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal PHESL-1000BDeroyal Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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