Recall Z-1311-2021 ยท KNT Tubes, Gastrointestinal (And Accessories)
Hollister Incorporated
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.
| Date | Feb 11, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Hollister has instructed the affected consignees to quarantine the affected inventory and discard the product per their local procedures for product destruction. |
| Quantity | 1,031 boxes (5,155 eaches) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932855 | HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE Hollister, Inc., Oct 13, 1993 |