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Sources: EU EUDAMED, US FDA
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FDA Recall
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Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 8, 2005
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.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004