FDA issues Class I recall of infusion pump batteries due to risk of burns
The U.S. Food and Drug Administration (FDA) has issued a Class I alert on behalf of Smiths Medical, urging providers to take notice of updated instructions for a line of infusion pump batteries. If damaged, rechargeable battery packs for CADD-Solis Li-ion infusion systems are at risk of melting, possibly causing severe burns to patients or caregivers. Further, damaged batteries may not hold a charge properly, leaving infusion pumps inoperable.
There have been no reports of injuries. However, due to the potentially dangerous nature of the damaged rechargeable batteries, this recall has been designated as the most serious type by the FDA. Damaged batteries must be recalled and replaced in accordance with new instructions issued by Smiths Medical.
However, the CADD-Solis Li-ion infusion pumps themselves are not subject to this recall and providers may continue to use them if the batteries are deemed safe.
What is being recalled?
All lots of rechargeable battery packs used in CADD-Solis Li-ion infusion pump systems are subject to the recall. All serial numbers of the affected products will need to be examined for damage and replaced if necessary.
- Product Names: CADD-Solis Rechargeable Battery Packs
- List Number: 21-2160-XX
Next steps
Check the outer case of recalled batteries for any signs of damage immediately. If there are dents or significant markings, do not use them. Use another battery pack in the infusion pump, or use four new AA batteries.
All known customers with affected batteries have been sent an Urgent Medical Device Correction letter by Smiths Medical with the instructions, as well as information on how to obtain replacement batteries. Distributors selling the batteries should notify customers of the need to inspect the casings for damage.
Damaged battery packs should be reported by users either by email at globalcomplaints@icumed.com or by phone at 1-866-216-8806. Customers with a battery should contact smithsmedical5437@sedgwick.com or their local representative for a replacement battery or credit.
The full recall notice from the FDA can be found here.
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