Public recall detail

Disposable Rotatable Clip Fixing Device

2023-03-17

medium
Recall Safety notice
Quick summary

Quick summary: Disposable Rotatable Clip Fixing Device. Date: 2023-03-17.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Disposable Rotatable Clip Fixing Device. Date: 2023-03-17.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOLYMPUS MEDICAL SYSTEMS CORP.
ProductDisposable Rotatable Clip Fixing Device
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73339

Affected products

ProductDisposable Rotatable Clip Fixing Device
LotContact the manufacturer.
ModelHX-201LR-135 HX-201UR-135
Serial numberContact the manufacturer.
DescriptionDisposable Rotatable Clip Fixing Device

Issue

Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment, prolonged episode of care, and unexpected medical intervention are the potential harms associated with clip nondeployment. Recall start date: February 23. 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73339
Background{}
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
AudiencesHealthcare
Source updated2023-03-17

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...