EndoTherapy Accessories (2021-01-04)
- Starting date:
- January 4, 2021
- Posting date:
- January 22, 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-74823
Last updated: 2021-01-22
Affected Products
- SINGLE USE ASPIRATION NEEDLE NA
- SINGLE USE GUIDE SHEATH KIT
- SPHINCTEROTOMES
- DISPOSABLE CANNULAS
- DISPOSABLE NEEDLES
- ELECTROSURGICAL SNARES
- DISPOSABLE BALLOON CATHETERS
- SINGLE USE ASPIRATION NEEDLE
- SINGLE USE ASPIRATION NEEDLE-TRACHEOBRONCHIAL TREE AND ESOPHAGUS
- SINGLE USE 3-LUMEN EXTRACTION BALLONS
- SINGLE USE ELECTROSURGICAL KNIFE
- SINGLE USE ELETROSURGICAL KNIFE - UPPER DIGESTIVE TRACT
- SINGLE USE ELECTROSURGICAL KNIFE
- SINGLE USE INJECTOR
- DUAL KNIFE J
- SINGLE USE ELECTROSURGICAL SNARE SD-400
Reason
Olympus Medical Systems Corp. Identified an abnormality during the packaging process of certain lot numbers of single-use products. Due to the anomaly, is it possible that the sterility of these products may be compromised due to a defective seal. This breach may be difficult to detect with the naked eye. Olympus has not received any reported complaints regarding compromised sterile package heat seals or injury associated with this matter. To prevent potential risk to patient health, Olympus will notify facilities who have received the affected lot numbers and request that the devices be quarantined and return to Olympus.
Affected products
A. SINGLE USE ASPIRATION NEEDLE NA
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- NA-410D-1321
- NA-410D-1521
- NA-411D-1321
- NA-411D-1521
- NA-601D-1519
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
B. SINGLE USE GUIDE SHEATH KIT
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- K-201
- K-202
- K-203
- K-204
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
C. SPHINCTEROTOMES
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- KD-620LR
- KD-620UR
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
D. DISPOSABLE CANNULAS
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
PR-V614M
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
E. DISPOSABLE NEEDLES
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
F. ELECTROSURGICAL SNARES
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- SD-210U-10
- SD-210U-15
- SD-210U-25
- SD-230U-20
- SD-240U-10
- SD-240U-15
- SD-240U-25
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
G. DISPOSABLE BALLOON CATHETERS
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- B5-2C
- B5-2Q
- B7-2LA
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
H. SINGLE USE ASPIRATION NEEDLE
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
NA-201SX-4022-A
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
I. SINGLE USE ASPIRATION NEEDLE-TRACHEOBRONCHIAL TREE AND ESOPHAGUS
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
NA-201SX-4021
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
J. SINGLE USE 3-LUMEN EXTRACTION BALLONS
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- B-V233P-A
- B-V243Q-A
- B-V443Q-A
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
K. SINGLE USE ELECTROSURGICAL KNIFE
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
KD-650U
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
L. SINGLE USE ELETROSURGICAL KNIFE - UPPER DIGESTIVE TRACT
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- KD-611L
- KD-640L
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
M. SINGLE USE ELECTROSURGICAL KNIFE
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
KD-612U
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
N. SINGLE USE INJECTOR
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- NM-610L-0521
- NM-610U-0326
- NM-610U-0423
- NM-610U-0426
- NM-610U-0523
- NM-610U-0525
- NM-610U-0623
- NM-610U-1826
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
O. DUAL KNIFE J
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- KD-655L
- KD-655U
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN
P. SINGLE USE ELECTROSURGICAL SNARE SD-400
Lot or serial number
More than 10 numbers, contact manufacture
Model or catalog number
- SD-400U-10
- SD-400U-15
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN