Medical device recalls Moderate risk

Medline Industries Inc recalls Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two bo…

Recall date
January 31, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0174-2020
FDA classification
Class II
Brand / firm
Medline Industries Inc
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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