FDA Medical Device Recall

Manufacturer: Cook Inc.

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570The Entuit Secure Gastrointestinal Suture Anchor Set Is Intended For Anchoring The Anterior Wall Of The Stomach To The Abdominal Wall Prior To The Introduction Of Interventional Catheters.

Recall Reason: There Is A Potential For Difficulty In Sliding Down The Retention Mechanism On The Sets Manufactured With A Specific Extension Spring Lot.

Recall Action:

The Firm, Cook Medical, Sent An "URGENT: MEDICAL DEVICE RECALL" Letters Dated 12/19/18 To Its Customers. The Letter Described The Product, Problem And Actions To Be Taken. The Customers Were Instruct To Do The Following: 1. Examine Your Inventory Immediately To Determine If You Have Affected Product(s), And Quarantine Affected Product(s). Immediately Cease All Distribution And Use Of These Products. 2. Return The Affected Product(s) To Cook Medical With A Copy Of The Acknowledgement And Receipt Form To Receive A Product Credit. NOTE: Unaffected Products That Are Returned Will Not Be Credited. 3. Please Complete The Acknowledgement And Receipt Form Within 5 Business Days Of Receiving This Letter. Even If You Do Not Have Affected Product(s) On Hand, You Must Still Complete The Acknowledgement And Receipt Form And Return It Via Fax (812.339.7316) Or Email (FieldActionsNA@CookMedical.com). 4. Immediately Report Adverse Events To Cook Medical Customer Relations By Phone At 800.457.4500 Or 812.339.2235, Monday Through Friday Between 7:30 Am And 5:00 Pm (Eastern Time) Or By Email To CustomerRelationsNA@CookMedical.com. If You Have Any Questions Or Concerns, Please Contact Cook Medical Customer Relations At 800.457.4500 Or 812.339.2235.

Recall Event Details

• Recall Date: 2019-02-28
• Date Initiated: 2018-12-19
• Date Created: 2019-02-28
• Reason for Recall: There Is A Potential For Difficulty In Sliding Down The Retention Mechanism On The Sets Manufactured With A Specific Extension Spring Lot.
• FDA Reason: Under Investigation By Firm
• Code Info: Lot Numbers 8056941,8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427,8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134
• Quantity: 975
• Distribution: Worldwide Distribution: US (nationwide) To Of States: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, And UT; And Countries Of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, And Switzerland.
• Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• Contact Number: 812-339-2235
• Recall ID / Product ID: 170519 / 170519
• Recall Event ID: 81979
• Recall Number: Z-0968-2019
• Recall Class: FDA Class 2 Medical Device
• 501(k) Number: K152524
• Status: Open3, Classified
• Product Class: Stents, Drains And Dilators For The Biliary Ducts
• Product Code: FGE