FDA Device recall Z-0564-2015
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral acces…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral acces… 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-0564-2015 |
| 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
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage: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. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
Reason
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Identifiers
| code_info | Lot No. 1301-038 |
|---|
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-0564-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.