The Recall Desk
HighFDA (Devices)·Z-0567-2015·Announced 2014-12-17

PFM Medical Recalls Veta Peritoneal Catheter Kits for Bacterial Endotoxin

PFM Medical is recalling Veta Peritoneal Catheter Kits because they may exceed USP limits for bacterial endotoxin.

What this means for you

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 are reported in the source text, fitting the 'High' severity criteria.

Plain-English summary

PFM Medical is recalling Veta Peritoneal Catheter Kits, Curled, Ref No. M7225. The recall involves 85 units from Lot No. 1212-005. These catheters are intended for acute and chronic access to the peritoneal cavity.

The recall was initiated because the devices may exceed USP limits for bacterial endotoxin. The agency classification for this recall is Class II.

The affected products were distributed nationwide in the United States in the states of Massachusetts, North Carolina, Utah, Pennsylvania, Texas, Ohio, and Louisiana, as well as worldwide to Germany and Malaysia. Consumers and healthcare providers should stop using the affected products and contact PFM Medical for further instructions.

The recalled product

Product
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
Manufacturer
Pfm Medical Inc
Affected units
85

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. 1212-005

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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.

See all 9 products in this recall →