Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthc
Summary
The FDA issued a Class II for Turbett Surgical Container, TS1200: Indicated for enclosing other medical device by Turbett Surgical, Inc.. Reason: Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries..
Details
Source
Device Recall
External ID
Z-1037-2023
Action Date
2023-02-08
Status
Ongoing
Category
device
Product Description
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Lot/Code Info: GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers
Quantity Affected: 61 units
Reason for Recall
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Distribution
US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-05
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 122 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-1037-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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