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.
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. The hazard involves bacterial endotoxin, which is a high-risk pathogen/contaminant, but the source text does not report any specific illnesses or injuries, placing it in the High severity category per the rubric.
Plain-English summary
Pfm Medical Inc is recalling 83 units of the ASEPT Peritoneal Drainage System, Reference No. P09080002. The product is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen. The recall is being conducted because the devices may exceed USP limits for bacterial endotoxin.
The affected units are identified by Lot No. 1211-002 and 1210-016. These products were distributed nationwide in the United States, specifically in Massachusetts, North Carolina, Utah, Pennsylvania, Texas, Ohio, and Louisiana. The devices were also distributed worldwide to Germany and Malaysia.
Consumers and healthcare providers should stop using the affected products and contact Pfm Medical Inc for further instructions on how to return or dispose of the devices.
The recalled product
- 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.
- Manufacturer
- Pfm Medical Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 83
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 (2)
- Lot No. 1211-002
- 1210-016
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.
See all 9 products in this recall →Related recalls
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