Health product recall

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

  1. SINGLE USE ASPIRATION NEEDLE NA
  2. SINGLE USE GUIDE SHEATH KIT
  3. SPHINCTEROTOMES
  4. DISPOSABLE CANNULAS
  5. DISPOSABLE NEEDLES
  6. ELECTROSURGICAL SNARES
  7. DISPOSABLE BALLOON CATHETERS
  8. SINGLE USE ASPIRATION NEEDLE
  9. SINGLE USE ASPIRATION NEEDLE-TRACHEOBRONCHIAL TREE AND ESOPHAGUS
  10. SINGLE USE 3-LUMEN EXTRACTION BALLONS
  11. SINGLE USE ELECTROSURGICAL KNIFE
  12. SINGLE USE ELETROSURGICAL KNIFE - UPPER DIGESTIVE TRACT
  13. SINGLE USE ELECTROSURGICAL KNIFE
  14. SINGLE USE INJECTOR
  15. DUAL KNIFE J
  16. 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