Z-2558-2020Class I

BodyGuard Microset, REF: A120-160XSFK

Name: Z-2558-2020 BodyGuard Microset, REF: A120-160XSFK
Creator: CME America, LLC
Published: 2020-06-16
License: https://open.fda.gov/license/

CME America, LLC / initiated 2020-06-16 / Terminated / root cause: design

FDA source

CME America, LLC began a recall of BodyGuard Microset, REF: A120-160XSFK on 2020-06-16. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2558-2020
Classification: Class I
Status: Terminated
Initiated: 2020-06-16
Posted: 2020-07-15
Terminated: 2022-05-09
Recalling firm: CME America, LLC
Product: BodyGuard Microset, REF: A120-160XSFK
Product code: FPA Set, Administration, Intravascular
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
Root cause tag: design
FDA root cause: Device Design
Action: On 06/16/20, Urgent Medical Device Recall Correction and Removal notices were emailed and mailed to customers and distributors. These notices provided additional information about the administration sets that were first identified in another recall notification issued on 04/27/20: www.bd.com/en-us/support/recall-notifications/recall-notification---cme-america-bodyguard-infusion-pump-system Customers ere asked to take the following immediate actions: 1) Share this letter with all users of the product within your facility to ensure awareness and understanding of this notice. 2) Identify any remaining inventory of infusion sets in Category C and D, document the infusion sets on the Customer Response Form, and discard following your institution s policy for destruction. 3) Identify any remaining inventory of infusion sets in Category B and document that on the Customer Response Form. Labels stating, in part, do not use for flow rates greater-than 500mL/hr, will be provided upon receipt of response forms, so customers may affix them to those devices. The quantity of Category A sets should be noted on the response form. Category A sets can be used for non-critical medications where plus/minus 13% accuracy does not adversely impact patients. There is no flow rate restriction for these sets. The recalling firm is suspending further distribution of the infusion pump system until further notice and will remove these products from the U.S. market. The firm will work with customers to facilitate a smooth transition away from the product. A supply of infusion sets in Category A and Category B will be maintained to support the Infusion Pumps remaining at facilities until the removal or disposal of pump(s) is complete. Distributors were asked to email customer lists to the recalling firm so the recalling firm can notify these customers directly. Customers with additional questions were encouraged to call Customer/Technical Support at 877-263-0111 between 8AM to 5PM MDT.
Quantity in commerce: 273700
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
Product codes and lots: All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2558-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2553-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2554-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2555-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2556-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2557-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2558-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2559-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2560-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2561-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2562-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2563-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2564-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2565-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2566-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2567-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2568-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2569-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2570-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2571-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2572-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2573-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2574-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2575-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2576-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2577-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2578-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2579-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2580-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2581-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2582-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2583-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2584-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2585-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2586-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2587-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2588-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15
Z-2589-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-15

Product code FPA

K042696Class IIBodyguard Infusion Pump SystemCaesarea Medical Electronics , Ltd. / cleared 2005-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)