Golden, CO, United States
CME America, LLC recalls
6 recalls recorded since 2018, most recently on 30 July 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)3
Terminated Class II Medical devices
- Recall started
- 30 July 2020
- Terminated
- 8 March 2022
- Reason
- Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0530-2021, Z-0527-2021, Z-0528-2021, Z-0529-2021, Z-0526-2021, Z-0525-2021
- CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administrat
- CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of admini
- CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of adminis
- CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable
- CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of admin
- CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administrat
Terminated Class I Medical devices
- Recall started
- 16 June 2020
- Terminated
- 9 May 2022
- Reason
- Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- Distribution
- U.S: 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. OUS (Foreign): Canada, UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2557-2020, Z-2588-2020, Z-2566-2020, Z-2553-2020, Z-2558-2020, Z-2580-2020, Z-2589-2020, Z-2582-2020, Z-2571-2020, Z-2583-2020, Z-2565-2020, Z-2563-2020 and 25 more
- BodyGuard Microset, REF: A120-161XPS
- BodyGuard Microset With Female Luer, REF: A120-160XPSN
- BodyGuard Microset, REF: A120-160X2YB
- BodyGuard BodySet, REF: A120-160SAS
- BodyGuard Microset, REF: A120-160XSFK
- CMExpress Microbore Sets, REF: A120-161C
- BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
- BodyGuard set with Female Luer, REF: A120-003XSN
- and 29 more product lines
Terminated Class II Medical devices
- Recall started
- 27 February 2020
- Terminated
- 26 January 2022
- Reason
- The wall charger may not properly charge the infusion pump battery.
- Distribution
- U.S. Consignees: 3, IL, MO, KS OUS : 0 "No foreign consignees".
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0305-2021
- CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL
Terminated Class II Medical devices
- Recall started
- 14 January 2020
- Terminated
- 27 May 2021
- Reason
- The filter installed onto the tube set may have the incorrect pore size.
- Distribution
- US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1886-2020
- BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nut
Terminated Class I Medical devices
- Recall started
- 7 January 2020
- Terminated
- 14 April 2022
- Reason
- Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)
- Distribution
- U.S.: HI, OR, AR, MA, PA, OH, WY, CO, NE, NC, WA, TX, UT, MD, CA, KY, FL, NH, TN, NY, SD, MO, IL, WI, MN, RI, VA, DC, SC, NJ, ME, KS, CT, MI, LA, AK, NM, IA, MT, ID, AZ, AL, VT, IN, MS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1474-2020
- CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Terminated Class I Medical devices
- Recall started
- 16 September 2019
- Terminated
- 13 April 2022
- Reason
- When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
- Distribution
- US: CA, OH, PA, and TX OUS: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1442-2020
- BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.