Recall Z-0466-2025— Smiths Medical ASD, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2024-06-26. It names 2 FDA 510(k) clearances: K170982, K111275. Product: smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps. Reason: The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-26
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 more
- K111275 — CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Reason for recall
The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.
Data sourced from openFDA. This site is unofficial and independent of the FDA.