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FDA Medical Device Recall Series - June 2019

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Total 2019 Recalls as of June

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June 2019 Recalls

June 2019 FDA Recall List

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

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

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.

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