PFM Medical Recalls Thoracentesis and Paracentesis Procedure Trays
PFM Medical is recalling 75 units of Thoracentesis & Paracentesis Procedure Trays because they 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 and 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 is recalling 75 units of the Thoracentesis & Paracentesis Procedure Tray, Reference No. M7553, 850004. The recall is due to the possibility that the devices may exceed USP limits for bacterial endotoxin. The affected lots are 1212-001 and 1212-034.
The recalled trays are used for short-term percutaneous fluid drainage. The distribution was worldwide, including the United States (specifically Massachusetts, North Carolina, Utah, Pennsylvania, Texas, Ohio, and Louisiana) as well as Germany and Malaysia.
Consumers and healthcare providers should stop using the affected trays and contact PFM Medical for further instructions or a return.
The recalled product
- Product
- Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
- Manufacturer
- Pfm Medical Inc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 75
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. 1212-001
- 1212-034
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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