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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant injury or property damage reports, or as a baseline for this classification level.
Plain-English summary
PFM Medical is recalling the ASEPT 600 ml Drainage Kit, Reference No. 622287, M7052. This medical device is an accessory used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen. The recall is being conducted because the devices may exceed USP limits for bacterial endotoxin.
The recall involves 1,470 units from Lot No. 1307-065 and 1301-009. These products were distributed nationwide in the United States, specifically in Massachusetts, North Carolina, Utah, Pennsylvania, Texas, Ohio, and Louisiana. Additionally, the products were distributed worldwide to Germany and Malaysia.
Consumers and healthcare facilities should stop using the affected ASEPT Drainage Kits and contact PFM Medical for further instructions or a return. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Pfm Medical Inc
- Hazard
- Affected units
- 1,470
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. 1307-065
- 1301-009
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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