FDA Device recall Z-1468-2021
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressi…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressi… by Trinity Sterile, citing evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1468-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-23 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Trinity Sterile |
| Distribution | US |
Product
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Reason
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Identifiers
| code_info | Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1468-2021%22
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