FDA Medical Device Recall Series - July 2019
July 2019 FDA Recall List
UDI code (01) 00690103190007
- Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)
- All serial numbers below 16192 with software versions ≤ 2.60
- All lots are involved
- Product Codes: 870-07KIT, 870-09KIT
- Model 8100
- Manufacturing Dates: April 2011 to June 2017*
* This product was initially recalled on August 9, 2017 (FDA Recall # Z-0026-2018). The firm subsequently expanded the recall on April 13, 2018 to expand the volume of product impacted. On February 1, 2019, BD further expanded the recall to include all Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017.
- Cardiosave Hybrid IABP
- Cardiosave Rescue IABP
- CS300 IABP
- CS100/100i IABP
- All lot numbers
If your organization needs help coordinating logistics, etc. related to any of the above Recalls, please don’t hesitate to contact us.