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Open, Classified

Turbett Surgical Container, TS1500

FDA Recall Z-1111-2022 · Posted 2022-05-18

Recalling FirmTURBETT SURGICAL, LLC
Recall StatusOpen, Classified
Product CodeFRG
Date Initiated2022-04-01
Product Quantity232 units

Reason for Recall

Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

Firm Action

Firm notified customers on April 1, 2022 via email. Customers were instructed to immediately discontinue use of the product and quarantine the product.

Root Cause

Device Design

Distribution Pattern

Domestic distribution to PA, CA, and NY only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153025Turbett Surgical ContainerTurbett Surgical, LLC · 2016-01-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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