Z-0174-2020 Class II Ongoing
FDA device recall Z-0174-2020 was initiated by Medline Industries Inc on January 31, 2019 and is designated Class II. Reason for recall: Potential for the Semi-Rigid canister lid to fragment during use. The recall status is ongoing. Affected quantity: 750 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- January 31, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 750 eaches
Product 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 for Recall
Potential for the Semi-Rigid canister lid to fragment during use.
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.
Code Information
Model Numbers OR530, OR530H; Lot Numbers 20180914-1, 20180913-1, 20180916-1, 20180929-1