Devices

Device Recall Specialty Administration Set low adsorption

Model / Serial
Model # I8C290 (Reorder No. 21-0317-25) distributed outside of the United States contains Lot no.: FEB04T17 & APR04T09. Model # 8C290 (Reorder No. 21-0304-01) distributed within the United States contains Lot no.: FEB04T06, MAR04T07, APR04T23
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
worldwide.
Product Description
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States.
Manufacturer
Smiths Medical MD, Inc.
1 Event
- Recall of Device Recall Specialty Administration Set low adsorption

Manufacturer

Smiths Medical MD, Inc.

Manufacturer Address
Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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