The Recall Desk
HighFDA (Devices)·Z-1311-2021·Announced 2021-04-07

Hollister Recalls Vertical Drain Tube Attachment Devices Due to Separation Risk

Hollister Incorporated is recalling Vertical Drain Tube Attachment Devices (VTAD) because the tube holder can separate from the securing barrier, risking tube migration or loss.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for tube migration or loss, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Hollister Incorporated is recalling 1,031 boxes (5,155 individual units) of Vertical Drain Tube Attachment Devices (VTAD), Model 9782. The device is designed to stabilize and secure various catheters, surgical drains, and tubes ranging from 5 to 40 French. The recall covers units with UDI Primary Unit of Use DI Number 00610075097821 and Lot Numbers 0K02, 1A09, and lAlO.

The recall was initiated because the tube holder has the potential to separate from the barrier that secures the device to the patient's body. This separation could contribute to the risk of the attached tube, drain, or catheter migrating or being lost.

The affected products were distributed worldwide, including nationwide in the United States and in Canada. Specific US states listed include 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, and ND. Consumers and healthcare providers should stop using the affected devices and contact Hollister Incorporated for further instructions.

The recalled product

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.
Manufacturer
Hollister Incorporated
Category
Medical Device — Gastrointestinal Tube Accessories
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 1A09
  • and lAlO

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

Related recalls

Same manufacturer · Hollister Incorporated

See all →