REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injecta...
FDA Device Recall #Z-0898-2013 — Class II — December 13, 2012
Recall Summary
| Recall Number | Z-0898-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 13, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medical Components, Inc dba MedComp |
| Location | Harleysville, PA |
| Product Type | Devices |
| Quantity | 785 |
Product Description
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Reason for Recall
The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Distribution Pattern
USA Nationwide Distribution including the state of PA.
Lot / Code Information
Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.
Other Recalls from Medical Components, Inc dba MedComp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1184-2021 | Class II | Power Injectable CT Port insertion kits - Produ... | Jan 13, 2021 |
| Z-2940-2020 | Class II | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 1... | Jul 27, 2020 |
| Z-2216-2019 | Class II | 14F x 24CM SLX Double Lumen Full Tray Hemodialy... | Mar 13, 2019 |
| Z-2215-2019 | Class II | 14F x 20CM SLX Double Lumen Full Tray Hemodialy... | Mar 13, 2019 |
| Z-2217-2019 | Class II | 14F x 30CM SLX Double Lumen Full Tray Hemodialy... | Mar 13, 2019 |
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.