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NOVA-T INTRAUTERINE DEVICE (2015-12-22)
- Starting date:
- December 22, 2015
- Posting date:
- February 1, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-56916
Affected Products
- NOVA-T INTRAUTERINE DEVICE
Reason
Bayer observed an increase in reports of device breakage for Nova-T in 2015. The reported breakage was noticed during insertion, or shortly after insertion, in connection with expulsion of the T-body loop with attached threads.
Affected products
-
NOVA-T INTRAUTERINE DEVICE
Lot or serial number
- TU00VV7
- TU00Z67
- TU01108
- TU011WR
- TU013RK
- TU014KS
- TU0164H
Model or catalog number
- CU 200 AG
Companies
- Manufacturer
-
Bayer Inc.
2920 MATHESON BLVD. EAST
MISSISSAUGA
L4W 5R6
Ontario
CANADA