Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Summary
The FDA issued a Class II for Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, ST by Southmedic, Inc.. Reason: Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to d.
Details
Source
Device Recall
External ID
Z-0279-2023
Action Date
2022-11-30
Status
Ongoing
Category
device
Product Description
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Lot/Code Info: GTIN 620974002628, Lot number: W92761
Quantity Affected: 450 units
Reason for Recall
Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.
Distribution
US Nationwide distribution in the state of IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-27
Company
Barrie, N/A
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 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Southmedic, Inc. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
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 (Southmedic, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Southmedic, Inc. have FDA actions?
Southmedic, Inc. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0279-2023" 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