SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Conve...

FDA Device Recall #Z-0315-2018 — Class II — July 5, 2017

Recall Summary

Recall Number Z-0315-2018
Classification Class II — Moderate risk
Date Initiated July 5, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Centurion Medical Products Corporation
Location Williamston, MI
Product Type Devices
Quantity N/A

Product Description

SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.

Reason for Recall

Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD's recall due to particulate that could be expelled out of the needle if used for injection.

Distribution Pattern

US.

Lot / Code Information

Material Description Batch Expiration 1 CHT122O CHESTTUBETRAY 2017032350 2018-10 2017032250 2018-06 2017030650 2018-08 2017010550 2018-06 2016121450 2018-06 2016120750 2018-06 2 CHT13OS CHEST TUBE INSERTION TRAY 2017030750 2018-07 3 CHT154O CHEST TUBE INSERTION TRAY 2016112850 2018-06 4 CVI3750 PIGTAIL ACCESSORY BUNDLE 2016121550 2018-09 2016111750 2018-08 5 CV14265 VASCULAR ACCESS INSERT KIT - PEDIATRICS 2017032850 2018-07 6 CV14360 DIALYSIS KIT 2017032250 2018-07 7 PT16O LUMBAR PUNCTURE TRAY 2016120950 2018-03 8 TC7910 TRACHEOTOMY TRAY 2016051950 2018-07 2016050250 2018-07

Other Recalls from Centurion Medical Products Corporation

Recall # Classification Product Date
Z-1047-2020 Class II Centurion- Dressing Change Tray DT10290S CENTR... Dec 11, 2019
Z-1091-2020 Class II Centurion- ENT SNUF3 SNUFFER KIT Y Dec 11, 2019
Z-1063-2020 Class II Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENA... Dec 11, 2019
Z-1090-2020 Class II Centurion- Skin Prep Kits SB1280 SKIN SCRUB KI... Dec 11, 2019
Z-1058-2020 Class II Centurion- Umbilical Trays UVT1045 UMBILICAL A... Dec 11, 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.