PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 7, 2021 Initiated: February 11, 2021 #Z-1311-2021

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.

Details

Recalling Firm
Hollister Incorporated
Units Affected
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.
Location
Libertyville, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hollister Incorporated. Units affected: 1,031 boxes (5,155 eaches).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 7, 2021. Severity: Moderate. Recall number: Z-1311-2021.