Vortex Surgical Recalls 25GA I.D.D. Internal Delivery Devices Over Sterility Risks

What Happened

Vortex Surgical Inc. has issued a voluntary recall for its 25GA I.D.D. Internal Delivery Devices due to a potential compromise in the product’s sterile barrier. The company discovered that there may be voids located in the seals of the Tyvek pouches used to package the devices. Such defects can lead to bioburden contamination, increasing the risk of infection for patients.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
• Recall Number: Z-1250-2026
• Lot Number: 2410044
• Pouch UDI: 810123480456
• Box UDI: 810123480739
• Quantity: 14,789 units (8,651 in the U.S.; 6,138 internationally)

The products were distributed nationwide in the United States across 31 states (including CA, TX, NY, FL, and IL) and internationally to countries including Australia, China, Germany, Japan, and the United Kingdom, among others.

What You Should Do

Healthcare facilities and distributors should immediately check their inventory for the affected lot number (2410044). Affected units should be quarantined to prevent use. Vortex Surgical initiated the recall via a notification letter to customers. For information regarding the return process or to report issues, contact Vortex Surgical Inc. at 4 Research Park Dr Ste 124, Saint Charles, MO 63304.

Why This Matters

Maintaining a sterile barrier is essential for surgical instruments. A breach in this packaging could introduce contaminants into a sterile field, potentially leading to post-operative infections or other serious health complications for patients.

Source

Information provided by the FDA.