Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Summary
The FDA issued a Class II for Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only by Karl Storz Endoscopy. Reason: Flexible intubation endoscopes sterility assurance can not be confirmed..
Details
Source
Device Recall
External ID
Z-2589-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Lot/Code Info: UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
Quantity Affected: 218 units
Reason for Recall
Flexible intubation endoscopes sterility assurance can not be confirmed.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-07
Company
El Segundo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Karl Storz Endoscopy has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Karl Storz Endoscopy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Karl Storz Endoscopy have FDA actions?
Karl Storz Endoscopy has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2589-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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