CME America Recalls BodyGuard 323 Infusion Pumps for Over-Delivery Risk
CME America is recalling BodyGuard and BodyGuard 323 infusion pumps due to a potential for over-delivery of medication.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect (over-delivery) that poses a significant risk of injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
CME America, LLC is recalling BodyGuard and BodyGuard 323 infusion pumps due to the potential for an over-delivery of medication. The recall affects specific models, including 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA, and 100-603XSAP. The affected units are identified by having USA36A4.4 version of software.
A total of 3,186 units were distributed nationwide in the United States, as well as to VA, military, and government consignees, and in Canada. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and users should stop using the affected pumps and contact CME America for further instructions on the recall process.
The recalled product
- Product
- BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Pumps
- Hazard
- Affected units
- 3,186
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)
- All product with USA36A4.4 version of software affected
Distribution
Distributed nationwide across the United States.
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