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Recall Observatory FDA recall evidence

Device product

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Z-1038-2023

December 05, 2022

Class II

Product summary

Firm
Turbett Surgical, Inc.
Event
Event 91314
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-1038-2023

Official wording

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.

Code information: GTIN: 00859464007212 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

Distribution pattern: US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.