Device recall

Z-2419-2024: CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following…

FDA device recall · Class I · Smiths Medical ASD Inc.

Key facts

Recall number (Z-number) Z-2419-2024
Recall event 94225
Product CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous…
Product code MEA
Recalling firm Smiths Medical ASD Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K072144
FEI number 3012307300

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)