Home / Recalls / CME America, LLC / Z-2557-2020

Z-2557-2020 Class I Terminated

Recalled by CME America, LLC — Golden, CO

Recall Details

Product Type
Devices
Report Date
July 22, 2020
Initiation Date
June 16, 2020
Termination Date
May 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
345244

Product Description

BodyGuard Microset, REF: A120-161XPS

Reason for Recall

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 Pattern

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

Code Information

All lots within expiry date

Other recalls by CME America, LLC

  • Z-0530-2021 Class II — CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or flu (July 30, 2020)
  • Z-0526-2021 Class II — CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications (July 30, 2020)
  • Z-0525-2021 Class II — CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or flu (July 30, 2020)
  • Z-0528-2021 Class II — CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or (July 30, 2020)
  • Z-0529-2021 Class II — CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion (July 30, 2020)
  • Z-0527-2021 Class II — CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications o (July 30, 2020)
  • Z-2575-2020 Class I — BodyGuard Microset, REF: A120-003XS2YV (June 16, 2020)
  • Z-2587-2020 Class I — CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK (June 16, 2020)
  • Z-2571-2020 Class I — BodyGuard Microset with Filter, REF: A120-160XSFE (June 16, 2020)
  • Z-2585-2020 Class I — Standard BodySet with Needleless Connectors, REF: A120-125XS (June 16, 2020)