Turbett Surgical Container, TS1500
FDA device recall Z-1111-2022 · posted 2022-05-18 · Open, Classified
Recall details
- Recalling firm
- TURBETT SURGICAL, LLC
- Reason for recall
- Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FRG
- Quantity affected
- 232 units
- Distribution
- Domestic distribution to PA, CA, and NY only.
- Date initiated
- 2022-04-01
- Date posted
- 2022-05-18
- Location
- Victor, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Turbett Surgical Container (K153025) | Turbett Surgical, LLC | 2016-01-14 |