Z-2735-2020 Class I Ongoing
FDA device recall Z-2735-2020 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: 17019 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
- 17019 units
Product Description
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
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: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0