June 2019 FDA Med Device Recalls

FDA Medical Device Recall Series - June 2019

June 2019 FDA Recall List

6/18/2019 Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the Rated Burst Pressure

Models Affected:

5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248
5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252
5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257

Lots:

9234424, 9331618, 9212015, 9243035, 9320430, 9386804, 9338194, 9234423, 9278982, 9209468, 9248603, 9320429

Recall Details

6/21/2019 Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit

Models Affected:

Select Sheridan® branded Endotracheal Tubes and Connectors EIF-000361. Product sizes 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5 mm are included in this recall.

Lots:

Hudson RCI® Sheridan LTS®
Hudson RCI® Sheridan (CF, Preformed, HZT) 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm
Hudson RCI® Sheridan®/EZ-ENDO 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm
Hudson RCI® Sheridan® Uncuffed 6.0, 6.5, 7.0 mm
Sheridan/CF Novaplus® 7.0
Sheridan/HVT® Novaplus® 7.0, 7.5, 8.0, 8.5 mm

Recall Details

6/27/2019 Vyaire Medical Recalls the enFlow Fluid Warming System Disposable Cartridges Due to Potential Risk of Exposure to Elevated Levels of Aluminum Exposure to Patients

Models Affected:

980200EU enFlow – Disposable Cartridge
980202EU enFlow – Disposable Cartridge with IV Extension Set

Lots:

All lots

Recall Details

If your organization needs help coordinating logistics, etc. related to any of the above Recalls, please don’t hesitate to contact us.