Device 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.
Z-0174-2020
Product summary
- Event
- Event 82066
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 750 eaches
- Official record key
device-enforcement:Z-0174-2020
Official wording
Reason: Potential for the Semi-Rigid canister lid to fragment during use.
Code information: Model Numbers OR530, OR530H; Lot Numbers 20180914-1, 20180913-1, 20180916-1, 20180929-1
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.
Derived failure modes
-
Unknown
Potential for the Semi-Rigid canister lid to fragment during use.