Device 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.
Z-1886-2020
Product summary
- Firm
- CME America, LLC
- Event
- Event 85206
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,800 infusion sets from lot 90829 and 24,500 from lot 16201
- Official record key
device-enforcement:Z-1886-2020
Official wording
Reason: The filter installed onto the tube set may have the incorrect pore size.
Code information: Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201
Distribution pattern: US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
Derived failure modes
-
Unknown
The filter installed onto the tube set may have the incorrect pore size.