Recall Z-0174-2020— Medline Industries Inc
Class II · Ongoing
Class II FDA medical device recall by Medline Industries Inc, initiated 2019-01-31. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for the Semi-Rigid canister lid to fragment during use..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-01-31
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.