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HARMONIC ACE+7 SHEARS (2015-10-02)
- Starting date:
- October 2, 2015
- Posting date:
- October 27, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55592
Recalled Products
- HARMONIC ACE+7 SHEARS
- HARMONIC ACE+7 LAPAROSCOPIC SHEARS
Reason
Ethicon is recalling lots of HARMONIC ACE+7 shears with expiration dates of 2020-08 or earlier. Ethicon has determined that under extreme handling circumstances, a hole can occur in the Tyvek lid due to an interaction between the advanced hemostasis (green) button and the Tyvek lid which could compromise device sterility.
Affected products
A. HARMONIC ACE+7 SHEARS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HARH23
Companies
- Manufacturer
-
ETHICON ENDO-SURGERY, LLC.
475 CALLE C
GUAYNABO
00969
PUERTO RICO
B. HARMONIC ACE+7 LAPAROSCOPIC SHEARS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HARH36
HARH45
Companies
- Manufacturer
-
ETHICON ENDO-SURGERY, LLC.
475 CALLE C
GUAYNABO
00969
PUERTO RICO