Z-2208-2008

ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated...

Name: Z-2208-2008 ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated...
Creator: ICU Medical, Inc.
Published: 2008-06-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-06-11 / Terminated / root cause: sterility

FDA source

ICU Medical, Inc. began a recall of ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated for fluid flow directional control and for... on 2008-06-11. The reason FDA records is "Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2208-2008
Status: Terminated
Initiated: 2008-06-11
Posted: 2008-09-16
Terminated: 2010-04-13
Recalling firm: Abbott Medical
Product: ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
Product code: FMG Stopcock, I.V. Set
Reason for recall: Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
Root cause tag: sterility
FDA root cause: Process change control
Action: Every customer both direct and distributors who have purchased the affected lots were mailed a Product Recall Letter with attached fax-back Product Inventory Summary attachment on 06/11/2008 via fax and followed by UPS overnight delivery. The Product Recall Letter informed the customers of the reason for the recall and instructed them to complete and return the attached Product Inventory Summary. Instructions were also given for returning product in their inventory to ICU.
Quantity in commerce: 100
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: 44-504-R5, 558884, 570634, and 603566

Product code FMG

K060231Class IIClosed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockElcam Medical Acal / cleared 2006-04-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)