FDA (Devices) recall action 69666

Pfm Medical Inc recalled 9 products on 2014-12-17

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2014-12-17
Critical: 0
Units: 2,873

Why these products were recalled

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

HighFDA (Devices)··2014-12-17
PFM Medical Recalls Dual Lumen CT PICC Catheters for Bacterial Endotoxin
PFM Medical is recalling 90 units of 6F x 60 cm Dual Lumen CT PICC catheters because they may exceed USP limits for bacterial endotoxin.
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
Category
Distribution
7 states
SevereFDA (Devices)··2014-12-17
PFM Medical Recalls ASEPT Drainage Kits for Bacterial Endotoxin Concerns
PFM Medical is recalling ASEPT 600 ml Drainage Kits because they may exceed USP limits for bacterial endotoxin. The recall affects 1,470 units distributed in the US and abroad.
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.
Category
Distribution
7 states
HighFDA (Devices)··2014-12-17
Pfm Medical Recalls ASEPT Peritoneal Drainage Systems for Bacterial Endotoxin
Pfm Medical is recalling 83 units of the ASEPT Peritoneal Drainage System because the devices may exceed USP limits for bacterial endotoxin.
Product
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
Category
Distribution
7 states
HighFDA (Devices)··2014-12-17
Pfm Medical Recalls ASEPT Pleural Drainage Systems for Bacterial Endotoxin
Pfm Medical is recalling ASEPT Pleural Drainage Systems because they may exceed USP limits for bacterial endotoxin. The recall affects 120 units distributed in the US and internationally.
Product
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated
Category
Distribution
7 states
HighFDA (Devices)··2014-12-17
PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits
PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.
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
Category
Distribution
7 states
HighFDA (Devices)··2014-12-17
PFM Medical Recalls Veta Peritoneal Catheter Kits for Bacterial Endotoxin
PFM Medical is recalling Veta Peritoneal Catheter Kits because they may exceed USP limits for bacterial endotoxin.
Product
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
Category
Distribution
7 states
HighFDA (Devices)··2014-12-17
PFM Medical Recalls Thoracentesis and Paracentesis Procedure Trays
PFM Medical is recalling 75 units of Thoracentesis & Paracentesis Procedure Trays because they may exceed USP limits for bacterial endotoxin.
Product
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
Category
Distribution
7 states
HighFDA (Devices)··2014-12-17
Pfm Medical Recalls Rapid Centesis Catheters Due to Bacterial Endotoxin
Pfm Medical Inc is recalling Rapid Centesis Catheters because they may exceed USP limits for bacterial endotoxin. The recall affects 480 units distributed in the US and abroad.
Product
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
Category
Distribution
7 states
HighFDA (Devices)··2014-12-17
PFM Medical Recalls ASEPT Drainage Bags Due to Bacterial Endotoxin Concerns
PFM Medical is recalling ASEPT 2000 ml Drainage Bags because they may exceed USP limits for bacterial endotoxin. The recall affects 370 units distributed in the US and internationally.
Product
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
Category
Distribution
7 states