Z-1442-2020Class I

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml

Name: Z-1442-2020 BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml
Creator: CME America, LLC
Published: 2019-09-16
License: https://open.fda.gov/license/

CME America, LLC / initiated 2019-09-16 / Terminated / root cause: manufacturing process

FDA source

CME America, LLC began a recall of 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... on 2019-09-16. FDA classified it as Class I and gives the reason as "When using a specific tubing set with infusion pump system, may result in under deliver of fluids". 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-1442-2020
Classification: Class I
Status: Terminated
Initiated: 2019-09-16
Posted: 2020-03-11
Terminated: 2022-04-13
Recalling firm: CME America, LLC
Product: 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.
Product code: FRN Pump, Infusion
Reason for recall: When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Updated 10/7/2019: On 09/16/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via various methods (i.e., email, and written letter delivered by FedEx) along with a response form for customer acknowledgement. The notification informed customers, that all lots of its Microset tubing when used with their infusion pump system may under deliver fluids. The product was distributed beginning in October 2017. The firm is instructing customers to: 1. Immediately review their inventory for Catalog #A120-003XYVA and to discard all remaining inventory of the tube sets per their facility's guidelines 2. Share the Urgent Medical Device Recall notice with all users of the product with their facility to ensure awareness of this action. 3. Complete the attached Customer Response Form and return to the contact noted on the firm regardless of whether they have any affected material or not so that the Recalling Firm may acknowledge their receipt of the notification. Fax Number: 312-949-0333 or email to [email protected] are to indicate on the response form the quantity of the tube sets remaining in inventory and confirm this inventory has been discarded. 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, Monday thru Friday from 9am to 5pm Mountain Time for a list of alternate sets that are available. Customer/Technical Support - 303-936-4545 or 877-263-0111 toll free.
Quantity in commerce: 69400 infusion sets
Distribution: US: CA, OH, PA, and TX OUS: Canada
Product codes and lots: Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 13978 14057 14188 14545 14790 14966 15073 19486 19490 19492 19834 16173 14966 15073 15277 15434 15802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1442-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1442-2020	Class I	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10

Product code FRN

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)