Hollister Incorporated Recall 87351
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.
Hollister Incorporated Recall 87351 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1311-2021 |
| Event ID | 87351 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 1,031 boxes (5,155 eaches) |
| Recall 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. |
| Device Classification | 20210407 |
| Device Code Info | Model: 9782. UDI: Primary Unit of Use DI Number: 00610075097821. Lot Numbers: 0K02, 1A09, and lAlO |
| Center Classification Date | 20210326 |
| Recall Initiation Date | 20210211 |
| Recalling Firm | Hollister Incorporated |
| Initial Notification | Letter |
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