FDAClass IISeptember 22, 2021

BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL recall

BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564

Why was BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL recalled?

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Lots: 20026597 20026598 20096477 20106218 20115237 20126022 20126023

Product
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
Recalling firm
CAREFUSION
Quantity
29,130
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of CA, NZ, TW, AU, BE, VN, AR, MY, TH, KR, ID, PH, SG, BH, SA, HK, IN, CN, BR.
Recall date
September 22, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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