FDA Medical Device Recalls (openFDA)
CME America, LLC: 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.
- Recall number
- Z-1442-2020
- 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.
- Status
- Terminated
- Initiated
- 2019-09-16
- Posted
- 2020-03-11
- Terminated
- 2022-04-13
- Reason
- When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
- 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 BDRC11@bd.comCustomer 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
- 69400 infusion sets
- Distribution
- US: CA, OH, PA, and TX OUS: Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K042696"]
- PMA numbers
- not on file
- Product code
- FRN
- 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