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.
This recall has been terminated (originally issued February 11, 2021).
- Company
- Hollister Incorporated
- Recall Initiated
- February 11, 2021
- Terminated
- September 14, 2022
- Recall Number
- Z-1311-2021
- Quantity
- 1,031 boxes (5,155 eaches)
- Firm Location
- Libertyville, IL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Model: 9782. UDI: Primary Unit of Use DI Number: 00610075097821. Lot Numbers: 0K02, 1A09, and lAlO
Root Cause
Under Investigation by firm
Action Taken
Hollister has instructed the affected consignees to quarantine the affected inventory and discard the product per their local procedures for product destruction.