Summary
The FDA issued a Class II for Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 by Steris Corporation. Reason: The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may re.
Details
Source
Device Recall
External ID
Z-0079-2023
Action Date
2022-10-19
Status
Terminated
Category
device
Product Description
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Lot/Code Info: UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
Quantity Affected: 5 US; 62 OUS
Reason for Recall
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
Distribution
Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-02
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0079-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29