PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits
PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.
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 that may exceed USP limits for bacterial endotoxin, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
PFM Medical is recalling 100 units of the Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005. The recall was initiated because the devices may exceed USP limits for bacterial endotoxin.
These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCs. 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.
The affected lot number is 1302-014. The products were distributed nationwide in the United States in the states of MA, NC, UT, PA, TX, OH, and LA, as well as worldwide to Germany and Malaysia. Consumers and healthcare providers should stop using the affected devices and contact PFM Medical for further instructions.
The recalled product
- Product
- Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous…
- Manufacturer
- Pfm Medical Inc
- Hazard
- Affected units
- 100
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. 1302-014
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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