BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing:… recallZ-1442-2020 · CME America, LLC · initiated Sep 16, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CME America, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1442-2020
- Status
- Terminated
- Initiated by the company
- Sep 16, 2019
- Posted by the FDA
- Mar 11, 2020
- Recalling firm
- CME America, LLC
- Quantity
- 69400 infusion sets
- Product code
- FRN
- FDA submissions
- K042696
- Distribution
- US: CA, OH, PA, and TX OUS: Canada
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BodyGuard® Microset with Needleless Y-Site A120-003XYVACme America LLC · Set, Administration, Intravascular1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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