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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm February 08, 2017
Date Posted February 28, 2017
Recall Status1 Terminated 3 on July 18, 2019
Recall Number Z-1475-2017
Recall Event ID 76497
510(K)Number K103668  
Product Classification Biopsy needle - Product Code FCG
Product SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Code Information Lot number: B000000166
Recalling Firm/
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
800-448-3644 Ext. 2
Manufacturer Reason
for Recall
Handle may break during use.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FCG and Original Applicant = BOSTON ENDOSCOPIC ENGINEERING