Date Initiated by Firm | December 04, 2018 |
Create Date | July 15, 2022 |
Recall Status1 |
Terminated 3 on March 11, 2024 |
Recall Number | Z-1394-2022 |
Recall Event ID |
90448 |
Product Classification |
Scale, surgical sponge - Product Code FQA
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Product | Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 |
Code Information |
UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6 |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
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For Additional Information Contact | Jordan Greegor 269-539-7085 |
Manufacturer Reason for Recall | Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard. |
FDA Determined Cause 2 | Use error |
Action | Gauss notified customers with a notification letter dated Dec 4, 2018. The letter informed customers that the IFU would be updated in order to clarify proper technique for handling sponges and the calibration placard. No action was required by the customer as the IFU updates were automatically accessible to the user through the iPad application and automatically moved to the newest revision.
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Quantity in Commerce | 51 units |
Distribution | US Nationwide. |
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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