FDAClass IJuly 22, 2020

BodyGuard Microset w/ 0.2 mic filter and lower y-site recall

BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF

Why was BodyGuard Microset w/ 0.2 mic filter and lower y-site recalled?

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

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?

All lots within expiry

Product
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
Recalling firm
CME America, LLC
Quantity
6016
Distribution
U.S: CA, IN, LA, MO, FL, IL, ME, MN, CO, VA, OK, NE, GA, AL, KY, IA, MS, ID, TX, SC, OH, SD, NV, MI, WY, NC, PA, TN, KS, NJ, OR, AR, NM, MA, NY, DC, RI, MD, WA, WI, AZ, NH, UT, HI, AK, MT, ND, VT, CT. OUS (Foreign): Canada, UK
Recall date
July 22, 2020
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls