Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Reported: January 18, 2023 Initiated: December 15, 2022 #Z-0947-2023
Product Description
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
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.
Details
- Recalling Firm
- Stradis Healthcare
- Units Affected
- 600 units
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.. Recalled by Stradis Healthcare. Units affected: 600 units.
Why was this product recalled? ▼
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0947-2023.
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