| Class 2 Device Recall Suction Canister | |
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
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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
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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 |
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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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