Recall record at a glance
| Official record | Z-0062-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Smiths Medical ASD Inc. |
| Report date | Nov 8, 2017 |
| Recall initiation date | Sep 25, 2017 |
| Quantity | 1148189 units |
| Location | Minneapolis, MN, United States |
Official product description
CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).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).
Why the product was recalled
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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