Z-2734-2020 Class I Ongoing
FDA device recall Z-2734-2020 was initiated by Smiths Medical ASD Inc. on June 26, 2020 and is designated Class I. Reason for recall: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. The recall status is ongoing. Affected quantity: 35616 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- June 26, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35616 units
Product Description
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Reason for Recall
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Distribution Pattern
Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago
Code Information
Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1