Karl Storz Recalls Mislabeled High Flow Insufflation Tubing Pouches
Karl Storz Endoscopy is recalling 496 boxes of High Flow Insufflation Tubing because some inner pouches are mislabeled with the wrong catalog number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where inner pouches are mislabeled as a different product. This fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Karl Storz Endoscopy is recalling 496 boxes of STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10. The recall involves Lot #129241. The product is individually packaged in sterile pouches, with 10 pouches per cardboard box.
The recall was initiated because the label outside the cardboard box is correct, but the pouches inside some of the boxes were mislabeled as a different product. Specifically, some pouches are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
Distribution was made nationwide, including government distribution, and to Canada. There was no military distribution. Users should stop using the affected product and contact Karl Storz Endoscopy for further instructions.
The recalled product
- Product
- STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Hazard
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 #129241
Distribution
Distributed nationwide across the United States.
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