Recall record at a glance
| Official record | Z-1067-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Karl Storz Endoscopy |
| Report date | May 18, 2022 |
| Recall initiation date | Apr 1, 2022 |
| Quantity | All Serial Numbers manufactured/distributed since January 2018. |
| Location | El Segundo, CA, United States |
Official product description
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
Why the product was recalled
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Distribution information
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, and WY. O.U.S.: Mexico, Lebanon, and South Korea
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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