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Recall Observatory FDA recall evidence

Device 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.

Z-1311-2021

February 11, 2021

Class II

Product summary

Firm
Hollister Incorporated
Event
Event 87351
Status
Terminated
Classification
Class II
Quantity
1,031 boxes (5,155 eaches)
Official record key
device-enforcement:Z-1311-2021

Official wording

Reason: 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.

Code information: Model: 9782. UDI: Primary Unit of Use DI Number: 00610075097821. Lot Numbers: 0K02, 1A09, and lAlO

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.