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U.S. Department of Health and Human Services

Class 2 Device Recall LargeVolume IV Administration Sets

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 Class 2 Device Recall LargeVolume IV Administration Setssee related information
Date Initiated by FirmDecember 08, 2005
Date PostedMarch 18, 2006
Recall Status1 Terminated 3 on January 05, 2007
Recall NumberZ-0660-06
Recall Event ID 34691
510(K)NumberK811933 K991599 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product 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.
Code Information Lot number FEB04T06
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
Manufacturer Reason
for Recall		Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
FDA Determined
Cause 2		Other
ActionAffected customers were notified of the recall and asked to return or destroy any unused product.
Quantity in Commerce7 boxes of 30 Admin. Sets (210 sets in total)
DistributionSouth Carolina, Australia, Canada and Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FPA
510(K)s with Product Code = FPA
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