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U.S. Department of Health and Human Services

Class 2 Device Recall Vertical Drain Tube Attachment Device (VTAD)

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  Class 2 Device Recall Vertical Drain Tube Attachment Device (VTAD) see related information
Date Initiated by Firm February 11, 2021
Create Date March 26, 2021
Recall Status1 Terminated 3 on September 14, 2022
Recall Number Z-1311-2021
Recall Event ID 87351
510(K)Number K932855  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-40 French.
Code Information Model: 9782. UDI: Primary Unit of Use DI Number: 00610075097821. Lot Numbers: 0K02, 1A09, and lAlO
Recalling Firm/
Manufacturer		 Hollister Incorporated
2000 Hollister Dr
Libertyville IL 60048-3781
For Additional Information Contact
847-680-2128
Manufacturer Reason
for Recall		 The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.
FDA Determined
Cause 2		 Under Investigation by firm
Action Hollister has instructed the affected consignees to quarantine the affected inventory and discard the product per their local procedures for product destruction.
Quantity in Commerce 1,031 boxes (5,155 eaches)
Distribution Worldwide distribution - US Nationwide distribution including in the states of IL, CO, NJ, CA, AZ, TX, KS, NY, IN, SC, RI, ID, WV, OH, MT, MO, SD, MI, MA, PA, VA, FL, NE, OR, KY, GA, WA, OK, TN, NC, MD, MN, MS, LA , NM, ND and the country of Canada.
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 = KNT and Original Applicant = HOLLISTER, INC.
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