Smiths Medical MD, Inc. Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.
Brand
Smiths Medical MD, Inc.
Lot Codes / Batch Numbers
Lot number MAR04T22
Products Sold
Lot number MAR04T22
Smiths Medical MD, Inc. is recalling Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infu due to Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to clos. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Affected customers were notified of the recall and asked to return or destroy any unused product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
SC, PR
Page updated: Jan 10, 2026