HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Reported: September 1, 2021 Initiated: July 20, 2021 #Z-2356-2021
Product Description
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Reason for Recall
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 68960 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36. Recalled by Ethicon Endo-Surgery Inc. Units affected: 68960 units.
Why was this product recalled? ▼
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2356-2021.
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