FDA Recall Open, Classified

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.

Recall: Z-0174-2020 · Initiated January 31, 2019

Recall

Recall Number
Z-0174-2020
Event Number
82066
Firm
Medline Industries Inc
FEI Number
1417592
Product Code
KDQ
Status
Open, Classified
Root Cause
Process control
Initiated
January 31, 2019
Address
Three Lakes Drive, Northfield, IL, 60093

Description

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.

Reason

Potential for the Semi-Rigid canister lid to fragment during use.

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.

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.

Quantity

750 eaches