QUANTA SYSTEM SURGICAL SINGLE-USE LASER FIBERS (2021-04-20)
- Starting date:
- April 20, 2021
- Posting date:
- June 30, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75919
Last updated:
2021-06-30
Affected Products
A. QUANTA SYSTEM SURGICAL SINGLE-USE LASER FIBERS
B. QUANTA SYSTEM SURGICAL REUSABLE LASER FIBERS
Reason
Quanta System SpA was informed about some significant deviations of sterilization process parameter potentially ocurred in the Ethylene Oxide processes. Based on such information, we have identified certain batches for which we are unable to guarantee the primary sterility.
Affected products
A. QUANTA SYSTEM SURGICAL SINGLE-USE LASER FIBERS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
QUANTA SYSTEM S.P.A.
VIA ACQUEDOTTO, 109
SAMARATE
ITALY
B. QUANTA SYSTEM SURGICAL REUSABLE LASER FIBERS
Lot or serial number
H204118
Model or catalog number
EMP-FBX365HR
OFH703613
Companies
- Manufacturer
-
QUANTA SYSTEM S.P.A.
VIA ACQUEDOTTO, 109
SAMARATE
ITALY