Recall Z-0222-2025 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238, 21-2101-249, 21-2101-51, 21-2102-0200-02, 21-2102-249, 21-2102-51, 21-2111-0100-00, 21-2111
| Date | Oct 31, 2024 (initiated Jul 16, 2024) |
| Status | Open, Classified |
| Reason | Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable. |
| Root cause | Component design/selection |
| Action | Smiths Medical issued an URGENT MEIDCAL DEVICE CORRECTION to its consignees on 07/16/2024 via traceable mailing. The notice explained the issue, potential risk and requested the following actions be taken: 1. Examine the external condition of the battery pack and look for evidence of damage to the outer case. As stated in the battery pack Instructions for Use, if the battery pack housing is cracked or otherwise damaged, replace the battery pack. NEVER use a battery pack that appears damaged. A rechargeable battery pack must be replaced with either another CADD-Solis rechargeable battery pac |
| Quantity | 138039 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111275 | CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE Smiths Medical Asd, Inc., Feb 1, 2013 |