Z-0061-2018 Class II Terminated
FDA device recall Z-0061-2018 was initiated by Smiths Medical ASD Inc. on September 25, 2017 and is designated Class II. Reason for recall: Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. The recall status is terminated (terminated August 7, 2020). Affected quantity: 11170535 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2017
- Initiation Date
- September 25, 2017
- Termination Date
- August 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11170535 units
Product Description
Reason for Recall
Distribution Pattern
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