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U.S. Department of Health and Human Services

Class 2 Device Recall Safeliner Suction Canister

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  Class 2 Device Recall Safeliner Suction Canister see related information
Date Initiated by Firm February 09, 2023
Date Posted March 23, 2023
Recall Status1 Open3, Classified
Recall Number Z-1283-2023
Recall Event ID 91760
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Code Information GTIN 50749756377046, Lot 58447585 exp. 12/22/2027
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Theresa Marsee
865-362-6465
Manufacturer 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 2		 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 us at 865-362-6465 or email us at recalls@deroyal.com.
Quantity in Commerce 27,200 devices
Distribution US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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