CME America Recalls BodyGuard Microset Infusion Administration Sets
CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that could cause over-infusion or under-infusion of therapy.
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 agency classification is Class I, and the rubric mandates a score of at least 4 for FDA Class I recalls. The hazard involves significant delivery inaccuracy that could lead to over-infusion or under-infusion of therapy.
Plain-English summary
CME America, LLC is recalling 18,520 units of BodyGuard Microset infusion administration sets (REF: A120-161XYBS). The recall covers all lots within expiry.
The FDA identified that the infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. The agency states that use of the infusion pump system could cause over-infusion or under-infusion of therapy.
The affected products were distributed in the United States (including CA, IN, LA, MO, FL, IL, ME, MN, CO, VA, OK, NE, GA, AL, KY, IA, MS, ID, TX, SC, OH, SD, NV, MI, WY, NC, PA, TN, KS, NJ, OR, AR, NM, MA, NY, DC, RI, MD, WA, WI, AZ, NH, UT, HI, AK, MT, ND, VT, CT) and in Canada and the UK. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- BodyGuard Microset, REF: A120-161XYBS
- Manufacturer
- CME America, LLC
- Affected units
- 18,520
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