CME America, LLC: Medical Device Recalls in 2020

According to to data from the FDA, there were 46 medical device recalls made by CME America, LLC in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• 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.
• CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
• 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 nutritional fluids, and general IV fluid therapy in hospital and home care environments.
• BodyGuard Microset, REF: A120-003XS2YV
• BodyGuard Microset, REF: A120-112XSFK
• BodyGuard Microset, REF: A120-160GCFA
• BodyGuard Microset with Filter, REF: A120-160XSFE
• BodyGuard Microset, REF: A120-161XYB
• Standard BodySet with Needleless Connectors, REF: A120-125XS
• CMExpress Microbore Sets, REF: A120-160C2YRV
• CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
• CMExpress Microbore Sets, REF: A120-161C
• BodyGuard Microset, REF: A100-163XESV
• BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
• BodyGuard BodySet, REF: A120-160SAS
• CMExpress Microbore Set, REF: A120-160C
• BodyGuard set with Female Luer, REF: A120-003XSN
• CMExpress Microbore Set, REF: A120-161CYF
• BodyGuard Microset with Filter, REF: A100-163XESF
• BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
• BodyGuard Microset With Female Luer, REF: A120-160XPSN
• BodyGuard Microset, REF: A120-160XSFK
• BodyGuard Microset, REF: A120-161XPS
• BodyGuard Microset, REF: A120-160X2YB
• BodyGuard Microset, REF: A100-163XSL
• BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
• BodyGuard Microset, REF: A120-161XYBS
• BodyGuard Microset, REF: A120-160XYSF
• BodyGuard Microset, REF: A120-160XPS
• CMExpress Microbore Sets, REF: A120-160CYFRV
• BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
• BodyGuard Microset with Filter, REF: A100-164XESF
• BodyGuard Microset, REF: A120-161XPSV
• BodyGuard Microset, REF: A100-163XE90S
• BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
• BodyGuard Microset, REF: A120-125XSE
• BodyGuard Microset, REF: A100-163XSFL
• BodyGuard Microset, REF: A100-163XES
• 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 administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
• BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
• CMExpress Microbore Set, REF: A120-160CRV
• 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 administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
• 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 administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
• 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 routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
• 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 administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
• 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 administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).