SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
FDA Recall Z-1474-2017 · Posted 2017-02-28
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Recalling FirmMedtronic
Recall StatusTerminated
Product CodeFCG
Date Initiated2017-02-08
Date Terminated2019-07-18
Product Quantity1,096 Units (total for all products)
Reason for Recall
Handle may break during use.
Firm Action
A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
Root Cause
Nonconforming Material/Component
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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