FDA Device recall Z-0563-2015
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of… by Pfm Medical, citing PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0563-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-20 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pfm Medical |
| Distribution | US |
Product
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.
Reason
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Identifiers
| code_info | Lot No. 1302-014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0563-2015%22
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