BodyGuard Microset For Use with the BodyGuard Infusion Pump ***… — Class II medical device recall Z-1886-2020
Terminated recall by CME America, LLC, reported 2020-05-13, distributed nationwide. The filter installed onto the tube set may have the incorrect pore size.
| Recall number | Z-1886-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CME America, LLC, Golden, CO, United States |
| Recall initiated | 2020-01-14 |
| Classified | 2020-05-04 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2021-05-27 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10818666020006, 10818666020013 |
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.
Reason for recall
The filter installed onto the tube set may have the incorrect pore size.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1886-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.