Rigid Suction Canister 3000 CC and 2000 CC.
FDA Device Recall #Z-0352-2017 — Class II — August 10, 2016
Recall Summary
| Recall Number | Z-0352-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 10, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries Inc |
| Location | Mundelein, IL |
| Product Type | Devices |
| Quantity | 7,680 units |
Product Description
Rigid Suction Canister 3000 CC and 2000 CC.
Reason for Recall
Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
Distribution Pattern
US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA.
Lot / Code Information
RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx
Other Recalls from Medline Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0358-2022 | Class II | EVLP Convenience Pack/Kit | Oct 27, 2021 |
| Z-0362-2022 | Class II | Bedside PICC CDS Convenience Kit | Oct 27, 2021 |
| Z-0360-2022 | Class II | Major Vascular CDS Convenience Kit | Oct 27, 2021 |
| Z-0359-2022 | Class II | Neuro Convenience Kit | Oct 27, 2021 |
| Z-0361-2022 | Class II | Venous Access Pack-LF Convenience Kit | Oct 27, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.