Public recall detail

K360 Scalpel Handle

2022-09-08

medium
Recall Safety notice
Quick summary

Quick summary: K360 Scalpel Handle. Date: 2022-09-08.

Recommended action

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

Recall details

Quick summary: K360 Scalpel Handle. Date: 2022-09-08.

Official details

Affected product details

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

BrandHu-Friedy Mfg. Co., LLC
ProductK360 Scalpel Handle
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64534

Affected products

ProductK360 Scalpel Handle
Lot0522 0621 0521 0322
ModelK360
Serial number0522 0621 0521 0322
DescriptionK360 Scalpel Handle

Issue

Hu-Friedy has identified that the scalpel holder )tip/head of the device) may separate from the handle for certain lots of K360 Scalpel Handles. Should the tip fall off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth, and also present a choking hazard. Recall start date: August 26, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesHu-Friedy Mfg. Co., LLC 3232 N. Rockwell St., Chicago, Illinois, United Stated, 60618
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64534
Background{}
CompaniesHu-Friedy Mfg. Co., LLC 3232 N. Rockwell St., Chicago, Illinois, United Stated, 60618
AudiencesHealthcare Industry
Source updated2022-09-08

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

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