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.
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 high-risk pathogen indicator (bacterial endotoxin) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
PFM Medical is recalling the ASEPT 2000 ml Drainage Bag, Reference No. 622280, because the product may exceed USP limits for bacterial endotoxin. The ASEPT Drainage Bag is intended for use with the ASEPT Peritoneal Drainage Catheter for peritoneal drainage.
The recall involves 370 units from Lot No. 1210-028. 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.
Consumers and healthcare providers should stop using the affected drainage bags and contact PFM Medical for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Pfm Medical Inc
- Category
- Medical Device — Drainage Bags
- Hazard
- Affected units
- 370
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 (1)
- Lot No. 1210-028
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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