Z-1886-2020 Class II Terminated
FDA device recall Z-1886-2020 was initiated by CME America, LLC on January 14, 2020 and is designated Class II. Reason for recall: The filter installed onto the tube set may have the incorrect pore size. The recall status is terminated (terminated May 27, 2021). Affected quantity: 5,800 infusion sets from lot 90829 and 24,500 from lot 16201.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- January 14, 2020
- Termination Date
- May 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,800 infusion sets from lot 90829 and 24,500 from lot 16201
Product Description
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.
Distribution Pattern
US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
Code Information
Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201