FDAClass IIMarch 22, 2017

BNX Fine Need Aspiration System recall

BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

Why was BNX Fine Need Aspiration System recalled?

Handle may break during use.

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?

Lot number: B000000167

Product
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
Recalling firm
Medtronic
Quantity
1,096 Units (total for all products)
Distribution
US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls