ASEPT Pleural Drainage System recall: Endotoxin
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is…
Why was ASEPT Pleural Drainage System recalled?
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 1307-024, 1302-031, 1210-015
- Product
- ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is…
- Recalling firm
- Pfm Medical Inc
- Quantity
- 120 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)