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.
FDA Recall Z-1311-2021 · Posted None
Advertisement
Recalling FirmHollister Incorporated
Recall StatusTerminated
Product CodeKNT
Date Initiated2021-02-11
Date Terminated2022-09-14
Product Quantity1,031 boxes (5,155 eaches)
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.
Firm Action
Hollister has instructed the affected consignees to quarantine the affected inventory and discard the product per their local procedures for product destruction.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement