| Date Initiated by Firm | April 14, 2022 |
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| Date Posted | August 04, 2022 |
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| Recall Status1 |
Terminated 3 on February 20, 2025 |
| Recall Number | Z-1501-2022 |
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| Recall Event ID |
90578 |
| 510(K)Number | K153025 |
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| Product Classification |
Wrap, sterilization - Product Code FRG
|
| Product | Turbett Surgical Container, TS1500 |
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| Code Information |
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. |
| FEI Number |
3012421755
|
Recalling Firm/
Manufacturer |
Turbett Surgical, Inc.
668b Phillips Rd Ofc 1
Victor NY 14564-9741
|
| For Additional Information Contact | Jay Schainholz
201-788-5050 |
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Manufacturer Reason
for Recall | Devices were subject to unapproved rework processes. |
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FDA Determined
Cause 2 | Process control |
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| Action | The firm distributed recall notification to hospitals via email on 04/14/2022. The recall notification identifies the reason for recall of specific TS1500 units to be that the repair process employed could restrict the customer's ability to clean and visually check the device for cleanliness. This can be identified by the customer by evidence of bioburden or particulate buildup in the seams of the device. Inadequate or incomplete cleaning of the unit may compromise the sterility of the load.
The firm asks customers to immediately discontinue use of the device and complete the provided Return Response Form to Quality@Turbettsurgical.com. Turbett will contact customers to coordinate the replacement of the unit and correction of the recalled device.
Customers with any questions can call 585-755-0133x106 from Monday through Friday, from 8:00 AM to 4:30 PM. |
|---|
| Quantity in Commerce | 7 units |
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| Distribution | US Nationwide Nationwide: CO, FL, NC and PA. |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = FRG
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