This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
- Product Names: CADD-Solis Rechargeable Battery Packs
- List Number: 21-2160-XX
- Lot/Serial Numbers: All lot and serial numbers
What to Do
- Look for any evidence of damage to the outer case of affected devices.
- Do not use any battery packs that appear damaged.
- Replace any damaged battery packs with another rechargeable pack or with four AA batteries before use.
On July 16, 2024, Smiths Medical sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
- Inform all users and potential users of CADD-Solis rechargeable battery packs of the notice.
- Examine the outside of the battery pack for evidence of damage to the outer case.
- Never use a battery pack that appears to be damaged, as stated in the battery pack Instructions for Use.
- A rechargeable battery back that must be replaced should be replaced with another CADD-Solis rechargeable battery or with four AA batteries.
- Damaged battery packs should be reported by users by submitting as a complaint to globalcomplaints@icumed.com or by phone: 1-866-216-8806.
- Complete and return the response form attached to the letter to mailto:smithsmedical5437@sedgwick.com within 10 days even if there is no affected product. Contact a local representative for credit.
- Distributors should forward the notice to any customers who may have received potentially affected products and request they complete the response form.
Reason for Updates to Use Instructions
Smiths Medical is updating use instructions for CADD-Solis Li-ion Rechargeable Battery Packs due to a potential issue where battery pack damage may lead to a short within the battery that melts the pack casing and stops the battery from being able to charge.
The use of affected products may cause serious adverse health consequences, including burns, injuries related to delayed or interrupted therapy and death.
There have been no reported injuries. There have been no reports of death.
Device Use
CADD-Solis Li-ion Rechargeable Battery Packs are lithium-ion battery packs that are used as an alternate source of power for the CADD-Solis ambulatory infusion pump.
CADD-Solis ambulatory infusion pumps are indicated for infusions in blood vessels, (intravenous), under the skin (subcutaneous), into the abdomen (intraperitoneal), close to nerves, into a surgical site (intraoperative), between vertebrae in the spine (epidural space or subarachnoid spaces). They are used for treatments that require continuous infusion rates and/or an intermittent larger dose (bolus), and/or patient-controlled on-demand doses.
Contact Information
Customers in the U.S. with questions about this recall should contact Technical Support at TSC.Support@icumed.com or 1-800-241-4002, option 3.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
