HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
FDA device recall Z-0940-2023 · posted 2023-01-11 · Open, Classified
Recall details
- Recalling firm
- Stradis Healthcare
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OFF
- Quantity affected
- 1,176 units
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
- Date initiated
- 2022-12-15
- Date posted
- 2023-01-11
- Location
- Waukegan, IL
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