Karl Storz Fiberscope Recall Due to Incorrect Sterilization Instructions
Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
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 involves a medical device where a defect in sterilization instructions could lead to the use of non-sterile instruments, posing a risk of harm to patients, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Karl Storz Endoscopy is recalling 21 units of the RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1. The recall was initiated after a complaint investigation revealed that the instruction manual included with some of these scopes contains errors regarding the Quick Connector Kits (QCK) and tray information for the STERIS System 1E (SS1E) sterilization method.
The incorrect information in the manual means that if a user sterilizes the affected scopes using the SS1E method and relies on the manual for QCK details, the sterility of the reprocessed scope cannot be guaranteed. This defect poses a risk to patient safety by potentially allowing non-sterile instruments to be used in medical procedures.
The affected scopes were distributed in the United States (AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV) and Canada. Healthcare facilities and users should stop using the affected scopes and contact Karl Storz Endoscopy for instructions on how to proceed.
The recalled product
- Product
- Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Affected units
- 21
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)
- All Lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Karl Storz Endoscopy 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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