The Recall Desk
HighFDA (Devices)·Z-1281-2022·Announced 2022-06-29

BVI Wet-Field Eraser surgical devices shipped with incorrect tip configuration

Beaver Visitec International recalled 660 units of BVI Wet-Field Eraser surgical devices after discovering boxes labeled with one tip configuration contained a different tip design. This mismatch could affect surgical precision and hemostasis control.

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: This is a Class II medical device recall where the wrong surgical instrument configuration was shipped in incorrectly labeled boxes. While no adverse events have been reported, surgeons may have unknowingly used the incorrect tip configuration, which could impair hemostasis control and tissue removal during surgery.

Plain-English summary

Beaver Visitec International is recalling 660 units of BVI Wet-Field Eraser, 18GA Blunt Tip, 45-degree angle surgical devices (Part Number 221251, Lot 6045693). The recalled units were shipped in boxes labeled as the blunt-tip 45-degree model but contained a different product: the Wet-Field Eraser, 18GA Bevel Tip, Straight model (Part Number 221250).

The BVI Wet-Field Eraser is intended for use during surgery to remove tissue and control bleeding through high frequency electrical current. The two device models have different tip angles and edge configurations, which affects how the instrument performs during surgical procedures. Surgeons who received the wrong configuration may have used it without realizing the mismatch, potentially affecting surgical outcomes.

This recall affects devices distributed nationwide to healthcare facilities in Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Minnesota, Nevada, South Carolina, Texas, and Washington. Hospitals and surgical centers should verify their inventory to identify any affected lots. If the incorrect devices were used, clinicians should monitor patient outcomes for any complications related to improper hemostasis or tissue removal. Contact Beaver Visitec International for return or replacement of affected devices.

The recalled product

Product
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical / Electrosurgical
Hazard
  • product-mix-up
  • device-configuration-mismatch
  • surgical-error-risk

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 (1)

  • UDI-DI: 30886158010488 Lot Number: 6045693

Distribution

Distributed nationwide across the United States.

Related recalls

Same category