FDA Medical Device Recalls (openFDA)
CME America, LLC: 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.
- Recall number
- Z-1886-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-01-14
- Posted
- not on file
- Terminated
- 2021-05-27
- Reason
- The filter installed onto the tube set may have the incorrect pore size.
- 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
- 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.
- Lot, serial or model codes
- Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201
- 510(k) numbers
- ["K031749"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3006967710
- Firm city
- Golden
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28