Z-1311-2021Class II

Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) -

Name: Z-1311-2021 Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) -
Creator: Hollister Incorporated
Published: 2021-02-11
License: https://open.fda.gov/license/

Hollister Incorporated / initiated 2021-02-11 / Terminated

FDA source

Hollister Incorporated began a recall of Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters... on 2021-02-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1311-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-11
Posted: 2021-03-26
Terminated: 2022-09-14
Recalling firm: Hollister Incorporated
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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
FDA 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 in commerce: 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.
Product codes and lots: Model: 9782. UDI: Primary Unit of Use DI Number: 00610075097821. Lot Numbers: 0K02, 1A09, and lAlO

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1311-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1311-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-26

Product code KNT

K932855Class IIHollister Vertical Drain/tube Attachment DeviceHollister, Inc. / cleared 1993-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)