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Class 2 Device Recall Foley Catheter Insertion Tray |
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Date Initiated by Firm |
December 15, 2022 |
Date Posted |
January 11, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0931-2023 |
Recall Event ID |
91350 |
Product Classification |
Urinary drainage collection kit - Product Code PPG
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Product |
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile |
Code Information |
a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660;
b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466 |
Recalling Firm/ Manufacturer |
Stradis Healthcare 3600 Burwood Dr Waukegan IL 60085-8399
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For Additional Information Contact |
Tracy Melton 425-343-4613
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Manufacturer Reason for Recall |
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
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FDA Determined Cause 2 |
Process control |
Action |
Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form. |
Quantity in Commerce |
920 units |
Distribution |
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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