Karl Storz Udel Sterilization Tray Instructions for Use recall
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS)…
Why was Karl Storz Udel Sterilization Tray Instructions for Use recalled?
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)
- Product
- Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS)…
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 71892
- Distribution
- US: AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Canada, Venezuela, Barbados, GUAM, Puerto Rico, Mexico, Northern Mariana Islands, Trinidad & Tobago, Germany, Cayman Islands, Philippines, Japan, Dominican Republic, Panama, Bahamas, Ecuador, Suriname, American Virgin Islands, British Virgin Islands, Belize, Curacao, The Bahamas, Brazil, South Korea, Bermuda
- Recall date
- January 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)