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Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is i...

FDA Device Recall #Z-0647-2017 — Class I — October 21, 2016

Recall Summary

Recall Number Z-0647-2017
Classification Class I — Serious risk
Date Initiated October 21, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Centurion Medical Products Corporation
Location Williamston, MI
Product Type Devices
Quantity 1000 kits

Product Description

Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.

Reason for Recall

The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Centurion Kit Code ECVC1680 Kit Description SINGLE LUMEN INSERTION BUNDLE Lot Number(s) 2016062150 2016062950 2016070650 Centurion Kit Code ECVC4785 Kit Description SINGLE LUMEN BUNDLE Lot Number(s) 2016081550 Centurion Kit Code M11620HKIC Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016051050 2016053150 2016060750 2016061550 2016063050 2016072050 2016080250 2016091950 Centurion Kit Code M11620HKICNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016060750 2016072650 2016093050 2016101050 Centurion Kit Code M11620HS Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016052050 2016062850 2016082350 2016082650 2016090250 Centurion Kit Code M11620KC Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016050950 2016053150 2016060750 2016071250 2016080350 2016082950 Centurion Kit Code M11620KCNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016060850 2016061650 2016062050 2016070550 2016071950 2016080250 2016090750 Centurion Kit Code M12013K Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm) Lot numbers 2016071350 2016072050 2016092650 2016100650 Centurion Kit Code M12013KNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm) Lot numbers 2016072950 2016082450

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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.

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