FDA Device recall Z-1528-2024
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into centra…
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into centra… by Cook, citing packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1528-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-01 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | US |
Product
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490
Reason
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Identifiers
| code_info | UDI-DI/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1528-2024%22
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