Recalls / —
—#71862
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.
- FDA product code
- FMG — Stopcock, I.V. Set
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K060231
- Affected lot / code info
- Lot Numbers: 44-504-R5, 558884, 570634, and 603566
Why it was recalled
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 (FDA determination)
Process change control
Action the firm took
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.
Recalling firm
- Firm
- ICU Medical, Inc.
- Address
- 951 Calle, Amanecer San Clemente, California 92673-6212
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2008-06-11
- Posted by FDA
- 2008-09-16
- Terminated
- 2010-04-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #71862. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.