Z-1311-2021 Class II Terminated
FDA device recall Z-1311-2021 was initiated by Hollister Incorporated on February 11, 2021 and is designated Class II. 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 t… The recall status is terminated (terminated September 14, 2022). Affected quantity: 1,031 boxes (5,155 eaches).
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- February 11, 2021
- Termination Date
- September 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,031 boxes (5,155 eaches)
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.
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 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.
Code Information
Model: 9782. UDI: Primary Unit of Use DI Number: 00610075097821. Lot Numbers: 0K02, 1A09, and lAlO