CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
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 source text explicitly identifies the agency classification as Class I. Per the rubric, an FDA Class I recall must be scored as 4 (Severe) or higher, and the potential for over-infusion or under-infusion of therapy constitutes a significant risk of harm.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A100-163XE90S). The recall involves 390,230 units distributed across all 50 U.S. states, the District of Columbia, Canada, and the United Kingdom. All lots within their expiration dates are affected.
The recall was initiated because the infusion administration sets may have a delivery inaccuracy exceeding plus or minus 13 percent, with observed ranges from minus 42.8 percent to plus 17.5 percent. The use of these infusion pump systems could result in the over-infusion or under-infusion of medical therapy.
Healthcare facilities and consumers who have these products should stop using them and contact CME America for further instructions. The agency has classified this as a Class I recall.
The recalled product
- Product
- BodyGuard Microset, REF: A100-163XE90S
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Pumps
- Affected units
- 390,230
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 lots within expiry
Distribution
Part of a larger recall action
This product is one of 37 recalled by CME America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 37 products in this recall →Related recalls
Same manufacturer · CME America, LLC
See all →- SevereCME America Recalls NeoThrive Syringe Pumps Due to Motor Wear
FDA (Devices) · 2020-12-09
- HighCME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage
FDA (Devices) · 2020-12-09
- HighCME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks
FDA (Devices) · 2020-12-09
- HighCME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks
FDA (Devices) · 2020-12-09
- SevereCME America T-Syringe Pump Recall for Motor Wear and Fluid Damage
FDA (Devices) · 2020-12-09
Same hazard · delivery inaccuracy
See all →- HighAlung Technologies Recalls Hemolung Respiratory Assist System Infusion Pumps
FDA (Devices) · 2021-02-10
- SevereCME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
FDA (Devices) · 2020-07-22
- SevereCME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
FDA (Devices) · 2020-07-22
- SevereCME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
FDA (Devices) · 2020-07-22
- SevereCME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy
FDA (Devices) · 2020-07-22