Medical Device Recall: Wetfield Eraser Bipolar Hemostatic due to temperature exposure
McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.
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 risk-of-harm product (a surgical hemostatic device) where temperature exposure may have impacted effectiveness, creating potential risk to patient safety during surgery, though no injury has been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Wetfield Eraser Bipolar Hemostatic Eraser (Model 221265) medical devices distributed nationwide. The recall affects all devices received between June 1 and September 30, 2021.
The devices were exposed to elevated temperatures at the manufacturing facility from June through August 2021 prior to delivery. This temperature exposure may have impacted the devices' effectiveness in hemostatic control—their ability to stop bleeding during surgical procedures.
Surgical teams and healthcare facilities should verify that recalled devices from the affected period are not in active use. Contact McKesson Medical-Surgical Inc. for instructions on device replacement or proper disposal.
The recalled product
- Product
- Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- effectiveness-loss
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)
- GTIN: 00886158010524
- 30886158010525
Distribution
Distributed nationwide across the United States.
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