Z-1472-2017 Class II Terminated

Recalled by Medtronic — North Haven, CT

FDA device recall Z-1472-2017 was initiated by Medtronic on February 8, 2017 and is designated Class II. Reason for recall: Handle may break during use. The recall status is terminated (terminated July 18, 2019). Affected quantity: 1,096 Units (total for all products).

Recall Details

Product Type
Devices
Report Date
March 22, 2017
Initiation Date
February 8, 2017
Termination Date
July 18, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,096 Units (total for all products)

Product Description

BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

Reason for Recall

Handle may break during use.

Distribution Pattern

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

Code Information

Lot Number: B000000176, B000000181