BodyGuard Microset For Use with the BodyGuard Infusion recall
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for…
Why was BodyGuard Microset For Use with the BodyGuard Infusion recalled?
The filter installed onto the tube set may have the incorrect pore size.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201
- Product
- BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for…
- Recalling firm
- CME America, LLC
- Quantity
- 5,800 infusion sets from lot 90829 and 24,500 from lot 16201
- Distribution
- US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)