Recall Z-1311-2021— Hollister Incorporated

Name: FDA recall Z-1311-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-11

Class II · Terminated

Class II FDA medical device recall by Hollister Incorporated, initiated 2021-02-11, terminated 2022-09-14. It names one FDA 510(k) clearance: K932855. Product: 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: 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..

Recalling firm: Hollister Incorporated
Classification: Class II
Status: Terminated
Initiated: 2021-02-11
Terminated: 2022-09-14
Firm location: Libertyville, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K932855 — HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICEHollister, Inc.·cleared 1993-10-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.