Turbett Surgical Container TS1500: Unapproved Rework Processes
Turbett Surgical, Inc. is recalling the Turbett Surgical Container TS1500 because the affected units were subject to unapproved rework processes. Seven units were distributed to healthcare facilities in Colorado, Florida, North Carolina, and Pennsylvania.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported hospitalizations, illnesses, or injuries. Unapproved rework processes represent a manufacturing quality control defect, warranting recall without demonstrated patient harm.
Plain-English summary
The Turbett Surgical Container, TS1500, is being recalled due to unapproved rework processes. Turbett Surgical, Inc. identified that the manufacturing procedures used to rework these devices did not follow FDA-approved processes.
Seven units have been distributed to healthcare facilities in Colorado, Florida, North Carolina, and Pennsylvania. The affected lot and serial numbers are: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001, and 100081/2018031004.
Healthcare facilities and end users who have received one of these containers should immediately discontinue use and contact Turbett Surgical, Inc. for guidance on replacement or return. Verify your inventory against the provided lot numbers and segregate any affected units.
The recalled product
- Product
- Turbett Surgical Container, TS1500
- Manufacturer
- Turbett Surgical, Inc.
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
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