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U.S. Department of Health and Human Services

Class 2 Device Recall Suction Canister

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  Class 2 Device Recall Suction Canister see related information
Date Initiated by Firm January 31, 2019
Create Date October 22, 2019
Recall Status1 Open3, Classified
Recall Number Z-0174-2020
Recall Event ID 82066
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one case without the individual boxes. The "H" denotes a single quantity when being ordered.
Code Information Model Numbers OR530, OR530H; Lot Numbers 20180914-1, 20180913-1, 20180916-1, 20180929-1
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact
866-359-1704
Manufacturer Reason
for Recall		 Potential for the Semi-Rigid canister lid to fragment during use.
FDA Determined
Cause 2		 Process control
Action On about 01/31/2018 Medline notified customers via "URGENT RECALL" letter. Instructions included to immediately check inventory for and quarantine all affected product, complete and return the response form, and notify customers if the product has been further distributed and instruct them to return products to Medline Industries, Inc. Once the response form is received, return labels will be provided to return all affected product. For questions call 866-359-1704.
Quantity in Commerce 750 eaches
Distribution Nationwide distribution to AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MT, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, VA, VT, WI.
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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