Z-1886-2020Class II

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe -

Name: Z-1886-2020 BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe -
Creator: CME America, LLC
Published: 2020-01-14
License: https://open.fda.gov/license/

CME America, LLC / initiated 2020-01-14 / Terminated / root cause: manufacturing process

FDA source

CME America, LLC began a recall of 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... on 2020-01-14. FDA classified it as Class II and gives the reason as "The filter installed onto the tube set may have the incorrect pore size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1886-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-14
Posted: 2020-05-04
Terminated: 2021-05-27
Recalling firm: CME America, LLC
Product: 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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The filter installed onto the tube set may have the incorrect pore size.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/20/2019, the firm contacted its distributors via phone call to request that the affected lots not be further distributed pending the Recalling Firm's investigation and assessment for recall. On 01/15/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification to customers via email and FedEx informing them that the filter installed onto the tube set may have the incorrect pore size: -For the lot 90829, the specified size on the label is 0.2 microns. A portion of the tube sets were incorrectly packaged and have a pore size of 1.2 microns rather than 0.2 microns. -For the lot 16201, the specified size on the label is 1.2 microns. A portion of the tube sets were incorrectly packaged and have a pore size of 0.2 microns rather than 1.2 microns. Customer are instructed to take the following actions: 1. Immediately review their inventory for Catalog #A120-160XSFK/lot number 90829 and Catalog # A120-112XSFK/lot number 16201. Discard all remaining inventory of the tube sets per their facilitys guidelines. 2. Share this Urgent Medical Device Recall notice with all users of the product within their facility to ensure awareness of this action. 3. Complete the attached Customer Response Form and return it to the contact noted on the form regardless of whether you have any affected material or not so that we may acknowledge your receipt of this notification. Indicate on the response form the quantities of affected product remaining in inventory and confirm that this inventory has been discarded. Credit will be issued to customers for all discarded product. 4. Report any adverse health consequences experienced with the use of this product to the Recalling Firm. 5. Contact the Recalling Firm at 877-263-0111 (toll free) or 303-939-4545, Monday thru Friday from 9:00am to 5:00pm U.S. Mountain Time for a list of alternate sets that are available.
Quantity in commerce: 5,800 infusion sets from lot 90829 and 24,500 from lot 16201
Distribution: US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
Product codes and lots: Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1886-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1886-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04

Product code FPA

K031749Class IIBodyguard Infusion SystemCaesarea Medical Electronics , Ltd. / cleared 2003-08-21

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)