Z-0660-06

Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion...

Name: Z-0660-06 Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion...
Creator: Smiths Medical MD, Inc.
Published: 2005-12-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-12-08 / Terminated

FDA source

Smiths Medical MD, Inc. began a recall of 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)... on 2005-12-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0660-06
Status: Terminated
Initiated: 2005-12-08
Posted: 2006-03-18
Terminated: 2007-01-05
Recalling firm: Abbott Medical
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.
Product code: FPA Set, Administration, Intravascular
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 root cause: Other
Action: Affected customers were notified of the recall and asked to return or destroy any unused product.
Quantity in commerce: 7 boxes of 30 Admin. Sets (210 sets in total)
Distribution: South Carolina, Australia, Canada and Puerto Rico.
Product codes and lots: Lot number FEB04T06

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)