Z-0466-05

Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric...

Name: Z-0466-05 Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric...
Creator: Smiths Medical MD, Inc.
Published: 2004-12-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-12-03 / Terminated

FDA source

Smiths Medical MD, Inc. began a recall of Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 3 Model Numbers are used for... on 2004-12-03. The reason FDA records is "Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0466-05
Status: Terminated
Initiated: 2004-12-03
Posted: 2005-02-02
Terminated: 2006-06-25
Recalling firm: Abbott Medical
Product: Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 3 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 standard injection sites. Model Number I8C1230J (Reorder No. 21-0301-25) for product distributed to Japan. Model Number I8C1230 (Reorder No. (21-0318-25) for product distributed Internationally. Model Number 8C1230 (Reorder No. 21-0305-01) for product distributed within the United States.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate..
FDA root cause: Other
Action: Customers were sent a product Safety & Recall notification via email or regular mail begining 12/03/04 through 12/08/04. A Product Recall form requested the customer for feedback as to Quantity Used, Quantity to be Retained and Quantity to be returned . The Customer Recall Notication states that if no Administration Sets from alternative lots are available and the use of the volumetric pump is essential, follow the instructions in the attached Customer Information Bulletin, which describes how to identify a set which does not have the defect. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths.
Quantity in commerce: 31,320 units total: 6,150 units (205 cases) to Japan, 17,970 units (599 cases) Internationally &7,200 units (240 cases) within USA. ea case 30 units.
Distribution: worldwide.
Product codes and lots: Model # I8C1230J (Reorder No. 21-0301-25) distributed in Japan contains Lot No.: FEB04T28, MAR04T23 & MAR04T34. Model # I8C1230 (Reorder No. 21-0318-25) distributed outside the United States contains Lot No.: FEB04T22, MAR04T31, APR04T06 & APR04T10. Model # 8C1230 (Reorder No. 21-0305-01) distributed within the United States contains Lot No.: FEB04T27 & APR04T13.

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)