FDA Device recall Z-0562-2015
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT P…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT P… 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-0562-2015 |
| 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
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Reason
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Identifiers
| code_info | Lot No. 1307-065, 1301-009 |
|---|
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-0562-2015%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.