Medical Device Recall: Counterfeit Batteries in Plum Infusion Systems
Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which establishes a minimum severity score of 4. Although no deaths, serious injuries, or hospitalizations have been reported, the failure of infusion pump batteries poses a risk to patients dependent on these devices for medication delivery.
Plain-English summary
ICU Medical is recalling counterfeit batteries manufactured by CSB batteries that are being used with Plum Infusion Systems, including Plum 360, Plum A+, and Plum A+3 models. These counterfeit batteries are not original equipment manufacturer (OEM) batteries and have not been tested or validated for use with Plum Infusion Systems.
The non-OEM batteries fail to hold their charge properly. Reports indicate that infusion pumps using these counterfeit batteries display messages asking users to replace the batteries earlier than expected. These unauthorized batteries are being distributed by OSI Batteries and their customers without authorization from ICU Medical.
The counterfeit batteries have been distributed worldwide, including throughout the United States, Puerto Rico, and in Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland, Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay. Approximately 3,840 units have been identified.
Users of affected Plum Infusion Systems should verify that batteries match original ICU Medical specifications. Batteries can be identified as counterfeit if they lack the ICU Medical Test Label and CE Mark on the label. Counterfeit batteries may be identified by the yellow date code label on the battery side (codes W2401xxxx through W2406xxxx). Healthcare facilities should verify their battery stock and contact ICU Medical if they suspect they have received counterfeit batteries.
The recalled product
- Product
- Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 3,840
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2) CE Mark
Distribution
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