FDA Device recall Z-0947-2023
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20 by Stradis Healthcare, citing potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0947-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-15 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Healthcare |
| Distribution | US |
Product
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Reason
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Identifiers
| code_info | Assembly Number TM8823-1, UDI-DI: M752TM882310, Lot Number: 220110674 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0947-2023%22
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