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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
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