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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (bacterial endotoxin) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Pfm Medical Inc is recalling the ASEPT Pleural Drainage System, specifically the Pleural Drainage Catheter Kit (Ref No. P09080001, M7001). The recall is being conducted because the devices may exceed United States Pharmacopeia (USP) limits for bacterial endotoxin. The ASEPT Pleural Drainage System is a tunneled, long-term catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusions.
The recall involves 120 units from Lot Nos. 1307-024, 1302-031, and 1210-015. These products were distributed nationwide in the United States, specifically in Massachusetts, North Carolina, Utah, Pennsylvania, Texas, Ohio, and Louisiana, as well as internationally to Germany and Malaysia.
Healthcare providers and consumers should stop using the affected devices and contact Pfm Medical Inc for further instructions on the recall.
The recalled product
- 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…
- Manufacturer
- Pfm Medical Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot No. 1307-024
- 1302-031
- 1210-015
Distribution
Part of a larger recall action
This product is one of 9 recalled by Pfm Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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