Device recall: BodyGuard BodySet, REF: A120-160SAS
Class I FDA enforcement event 85650. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
CME America, LLC started this device recall on 16 Jun 2020. The firm address in the FDA record is in Golden, CO. FDA put the recall in Class I. FDA event 85650 has 37 product records. The first FDA enforcement report date is 22 Jul 2020. The record gives the status Terminated, with the termination date 9 May 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
CME America, LLC, Golden, CO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
37 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2553-2020 | BodyGuard BodySet, REF: A120-160SAS | 3250 | Class I | Terminated | 22 Jul 2020 |
| Z-2554-2020 | BodyGuard Microset, REF: A120-160XPS | 479559 | Class I | Terminated | 22 Jul 2020 |
| Z-2555-2020 | BodyGuard Microset, REF: A100-163XESV | 178057 | Class I | Terminated | 22 Jul 2020 |
| Z-2556-2020 | BodyGuard Microset, REF: A100-163XES | 140565 | Class I | Terminated | 22 Jul 2020 |
| Z-2557-2020 | BodyGuard Microset, REF: A120-161XPS | 345244 | Class I | Terminated | 22 Jul 2020 |
| Z-2558-2020 | BodyGuard Microset, REF: A120-160XSFK | 273700 | Class I | Terminated | 22 Jul 2020 |
| Z-2559-2020 | BodyGuard Microset, REF: A120-112XSFK | 1273892 | Class I | Terminated | 22 Jul 2020 |
| Z-2560-2020 | BodyGuard Microset, REF: A100-163XSFL | 146 | Class I | Terminated | 22 Jul 2020 |
| Z-2561-2020 | BodyGuard Microset, REF: A120-160XYSF | 50 | Class I | Terminated | 22 Jul 2020 |
| Z-2562-2020 | BodyGuard Microset, REF: A120-161XYB | 25746 | Class I | Terminated | 22 Jul 2020 |
| Z-2563-2020 | BodyGuard Microset, REF: A120-161XYBS | 18520 | Class I | Terminated | 22 Jul 2020 |
| Z-2564-2020 | BodyGuard Microset with Filter, REF: A100-163XESF | 95110 | Class I | Terminated | 22 Jul 2020 |
| Z-2565-2020 | BodyGuard Microset, REF: A120-161XPSV | 291386 | Class I | Terminated | 22 Jul 2020 |
| Z-2566-2020 | BodyGuard Microset, REF: A120-160X2YB | 5000 | Class I | Terminated | 22 Jul 2020 |
| Z-2567-2020 | BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY | 198160 | Class I | Terminated | 22 Jul 2020 |
| Z-2568-2020 | CMExpress Microbore Set, REF: A120-160CRV | 402026 | Class I | Terminated | 22 Jul 2020 |
| Z-2569-2020 | CMExpress Microbore Set, REF: A120-161CYF | 25286 | Class I | Terminated | 22 Jul 2020 |
| Z-2570-2020 | BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS | 500 | Class I | Terminated | 22 Jul 2020 |
| Z-2571-2020 | BodyGuard Microset with Filter, REF: A120-160XSFE | 16850 | Class I | Terminated | 22 Jul 2020 |
| Z-2572-2020 | BodyGuard Microset with Filter, REF: A100-164XESF | 55455 | Class I | Terminated | 22 Jul 2020 |
| Z-2573-2020 | BodyGuard Microset, REF: A100-163XE90S | 390230 | Class I | Terminated | 22 Jul 2020 |
| Z-2574-2020 | BodyGuard Microset, REF: A100-163XSL | 28600 | Class I | Terminated | 22 Jul 2020 |
| Z-2575-2020 | BodyGuard Microset, REF: A120-003XS2YV | 169856 | Class I | Terminated | 22 Jul 2020 |
| Z-2576-2020 | BodyGuard Microset, REF: A120-125XSE | 31484 | Class I | Terminated | 22 Jul 2020 |
| Z-2577-2020 | BodyGuard Microset, REF: A120-160GCFA | 29720 | Class I | Terminated | 22 Jul 2020 |
| Z-2578-2020 | CMExpress Microbore Sets, REF: A120-160CYFRV | 113482 | Class I | Terminated | 22 Jul 2020 |
| Z-2579-2020 | CMExpress Microbore Sets, REF: A120-160C2YRV | 4234 | Class I | Terminated | 22 Jul 2020 |
| Z-2580-2020 | CMExpress Microbore Sets, REF: A120-161C | 50122 | Class I | Terminated | 22 Jul 2020 |
| Z-2581-2020 | BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF | 8016 | Class I | Terminated | 22 Jul 2020 |
| Z-2582-2020 | BodyGuard set with Female Luer, REF: A120-003XSN | 7200 | Class I | Terminated | 22 Jul 2020 |
| Z-2583-2020 | BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV | 6320 | Class I | Terminated | 22 Jul 2020 |
| Z-2584-2020 | BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF | 6016 | Class I | Terminated | 22 Jul 2020 |
| Z-2585-2020 | Standard BodySet with Needleless Connectors, REF: A120-125XS | 36286 | Class I | Terminated | 22 Jul 2020 |
| Z-2586-2020 | CMExpress Microbore Set, REF: A120-160C | 13280 | Class I | Terminated | 22 Jul 2020 |
| Z-2587-2020 | CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK | 1824 | Class I | Terminated | 22 Jul 2020 |
| Z-2588-2020 | BodyGuard Microset With Female Luer, REF: A120-160XPSN | 50 | Class I | Terminated | 22 Jul 2020 |
| Z-2589-2020 | BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV | 152570 | Class I | Terminated | 22 Jul 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class I
- 4%
- Product records in this event
- 37Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Jul 2020 | CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent | Device | Class II | 6 |
| 27 Feb 2020 | CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ | Device | Class II | 1 |
| 14 Jan 2020 | BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: | Device | Class II | 1 |
| 7 Jan 2020 | CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpr | Device | Class I | 1 |
| 16 Sep 2019 | BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The Bod | Device | Class I | 1 |
| 16 Jan 2015 | BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2553-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 85650. https://recallregister.com/fda/i/85650/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 85650?
- The event has 37 product records. The first record gives this quantity:
3250
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 4% of the 916 device events that started in 2020 are in Class I.