—#170826

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.

FDA product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Model Numbers OR530, OR530H; Lot Numbers 20180914-1, 20180913-1, 20180916-1, 20180929-1

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170826. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.