Summary
The FDA issued a Class II for Turbett Surgical Container, TS1500 by Turbett Surgical, Inc.. Reason: Devices were subject to unapproved rework processes..
Details
Source
Device Recall
External ID
Z-1501-2022
Action Date
2022-08-10
Status
Terminated
Category
device
Product Description
Turbett Surgical Container, TS1500
Lot/Code Info: UDI-DI (GTIN): 00859464007113; Lot No./Serial No.: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001 and 100081/2018031004.
Quantity Affected: 7 units
Reason for Recall
Devices were subject to unapproved rework processes.
Distribution
US Nationwide Nationwide: CO, FL, NC and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-14
Company
Victor, NY
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 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Turbett Surgical, Inc. has 3 FDA actions in our database, including 3 recalls.
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 (Turbett Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Turbett Surgical, Inc. have FDA actions?
Turbett Surgical, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1501-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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