Ball Coarse, Interproximal Fine and Alpen SteriX RC 557 FG 50pk and SS 10pk (2019-12-19)
- Starting date:
- December 19, 2019
- Posting date:
- January 10, 2020
- 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-72085
Last updated: 2020-01-10
Affected Products
- Ball Coarse
- Interproximal Fine
- Alpen SteriX RC 557 FG 50pk and SS 10pk
Reason
These sterile products are being voluntarily recalled because the pouch seal may not have correctly sealed leading to potential beach in the sterile packaging.
Affected products
-
Ball Coarse
Lot or serial number
J64631
Model or catalog number
X801C018
Companies
- Manufacturer
-
Coltene/Whaledent, Inc.
235 Ascot Parkway
Cuyahoga Falls
44223
Ohio
UNITED STATES
B. Interproximal Fine
Lot or serial number
J64640
Model or catalog number
X392F016
Companies
- Manufacturer
-
Coltene/Whaledent, Inc.
235 Ascot Parkway
Cuyahoga Falls
44223
Ohio
UNITED STATES
C. Alpen SteriX RC 557 FG 50pk and SS 10pk
Lot or serial number
J63631
J69090
Model or catalog number
RS100557B
RS300557
Companies
- Manufacturer
-
Coltene/Whaledent, Inc.
235 Ascot Parkway
Cuyahoga Falls
44223
Ohio
UNITED STATES