PFM Medical Recalls Dual Lumen CT PICC Catheters for Bacterial Endotoxin
PFM Medical is recalling 90 units of 6F x 60 cm Dual Lumen CT PICC catheters 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 involves a medical device with a potential contamination hazard (bacterial endotoxin) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
PFM Medical is recalling 90 units of 6F x 60 cm Dual Lumen CT PICC catheters (Ref No. PFM2CT6D, Lot No. 1301-038). The recall was initiated because the devices may exceed USP limits for bacterial endotoxin.
The affected catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, blood sampling, infusions, or therapies. The products were distributed nationwide in the United States in the states of Massachusetts, North Carolina, Utah, Pennsylvania, Texas, Ohio, and Louisiana, as well as internationally to Germany and Malaysia.
Healthcare facilities and consumers should stop using the affected catheters and contact PFM Medical for further instructions or a replacement.
The recalled product
- Product
- 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or…
- Manufacturer
- Pfm Medical Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 90
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. 1301-038
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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