Z-1037-2023Class II

Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized...

Name: Z-1037-2023 Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized...
Creator: Turbett Surgical, Inc.
Published: 2022-12-05
License: https://open.fda.gov/license/

TURBETT SURGICAL, Inc / initiated 2022-12-05 / Open, Classified / root cause: design

FDA source

Turbett Surgical, Inc. began a recall of Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider on 2022-12-05. FDA classified it as Class II and gives the reason as "Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1037-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-05
Posted: 2023-01-30
Recalling firm: TURBETT SURGICAL, Inc
Product: Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Product code: FRG Wrap, Sterilization
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.
Root cause tag: design
FDA root cause: Device Design
Action: ***UPDATE*** Turbett Surgical issued via E-mails Product Alert directly to the Hospital departments utilizing the device on 12-27-2022. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Immediately discontinue the use of the specific devices exhibiting one or more failure(s) listed below. " Missing side supports " Broken or cracked side tab support " Backwall weld separation " Side weld separation " Crack in the backwall seam 2. Email ([email protected]) with the following information. " Hospital name " Serial number(s) " Type of failure that your container exhibited 3. Turbett Surgical will contact you to organize pick up of the damaged unit and shipment of a replacement unit. If your container does not exhibit any of these failures, please continue to monitor and inspect the condition of the container and follow the Instructions For Use (IFU) as you continue utilizing your container. 4. If your container does not exhibit any of these failures, please email [email protected] stating that your container(s) do not exhibit any of these failures. Please continue to monitor and inspect your devices prior to assembling for sterilization AS WELL AS after sterilization and cooling to ensure expected outcomes. Reminder to follow the Instructions For Use (IFU) as you continue utilizing your TS-1200 container. If you have any questions about the content of this letter, please contact Mark Petras at [email protected]. ________________________________________________________________________ Turbett Surgical issued Emails to the Hospital department on 12/7/2022. Sales representatives were notified on 12/5/22 to switch out the other container. Letter states reason for recall, health risk and action to take: 1. Immediately verify that the specific serial numbered devices listed below, continues to operate without creating wet loads or the sterilization process is not compromised.
Quantity in commerce: 61 units
Distribution: US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
Product codes and lots: GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1037-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1037-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30
Z-1038-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30

Product code FRG

K153025Class IITurbett Surgical ContainerTurbett Surgical, LLC / cleared 2016-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)