Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
- Company
- Karl Storz Endoscopy
- Recall Initiated
- July 7, 2023
- Posted
- September 15, 2023
- Recall Number
- Z-2589-2023
- Quantity
- 218 units
- Firm Location
- El Segundo, CA
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.
Lot / Code Info
UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
Root Cause
Process change control
Action Taken
On August, 4, 2023, Karl Storz Endoscopy issued an Urgent Medical Device Recall Notification via: UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of Material numbers listed above. 2. Pass on this Urgent Medical Device Recall notice to all users of the products listed above and all other persons who need to be aware within your organization. 3. If you have distributed the products listed, please promptly forward this letter to those recipients, and indicate contact details of the recipient on the Customer Reply From. 4. Return the filled Customer Reply Form by Fax or E-Mail to the indicated contact. 5. Get in touch with your KARL STORZ representative to return affected products. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. (Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.)