Five S 5 3x65 recall: Sterility Concern
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Why was Five S 5 3x65 recalled?
Flexible intubation endoscopes sterility assurance can not be confirmed.
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?
UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
- Product
- Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 218 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.
- Recall date
- September 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)