FDAFDA · Food and drugs·Recall number Z-0061-2018
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).
Published November 8, 2017 · Recall initiated: September 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Indonesia, Ireland, Italy, Luxembourg, Netherlands, Japan, Norway, Portugal, Saudi Arabia, Sweden, Belgium, Switzerland, Spain, China, Estonia, Hong Kong, Omen, Indonesia, Puerto Rico, Hungary, Israel, Singapore, Santa Domingo, New Zealand, Philippines, South Africa, Malaysia, and Lebanon
- Lot
- All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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