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Vertical Drain Tube Attachment Device (VTAD)… recallZ-1311-2021 · Hollister Incorporated · initiated Feb 11, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hollister Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

Hollister has instructed the affected consignees to quarantine the affected inventory and discard the product per their local procedures for product destruction.

Recall details

Recall number
Z-1311-2021
Status
Terminated
Initiated by the company
Feb 11, 2021
Recalling firm
Hollister Incorporated
Quantity
1,031 boxes (5,155 eaches)
Product code
KNT
FDA submissions
K932855
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.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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