The Recall Desk
LowFDA (Devices)·Z-2325-2012·Announced 2012-09-12

Steris recalls 77 packs of medical tubing due to failed process indicators

Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classification is Class III, which by definition indicates the product is unlikely to cause adverse health consequences. The source text does not report any injuries or illnesses.

Plain-English summary

Steris Corporation is recalling 77 packs of 100-foot rolls of medical tubing. The product is distributed in cardboard boxes and is used to seal medical devices prior to ethylene oxide sterilization, maintaining their sterility until opened.

The recall was initiated after the firm became aware on July 20, 2012, that a lot of tubing was distributed by the supplier after it had been rejected by Steris due to failing process indicators. The specific product code is KCT and the lot number is 60263.

The affected products were distributed worldwide, including nationwide in the United States and in Japan, Peru, and Suriname. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items.

The recalled product

Product
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Manufacturer
Steris Corporation
Affected units
77

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)

  • Product code KCT
  • Lot number: 60263

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically: