Pfm Medical Recalls Rapid Centesis Catheters Due to Bacterial Endotoxin
Pfm Medical Inc is recalling Rapid Centesis Catheters because they may exceed USP limits for bacterial endotoxin. The recall affects 480 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 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 involves a medical device with a potential contamination hazard (bacterial endotoxin) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Pfm Medical Inc is recalling 480 units of Rapid Centesis Catheters, 5 Fr x 7 cm (Ref No. M7513), because they may exceed USP limits for bacterial endotoxin. The product is used for short-term percutaneous fluid drainage.
The affected units are identified by Lot No. 1401-040. Distribution was worldwide, including the US states of Massachusetts, North Carolina, Utah, Pennsylvania, Texas, Ohio, and Louisiana, as well as Germany and Malaysia.
Healthcare providers and consumers should stop using the affected catheters and contact Pfm Medical Inc for further instructions.
The recalled product
- Product
- Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
- Manufacturer
- Pfm Medical Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 480
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. 1401-040
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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