| Date Initiated by Firm |
April 01, 2022 |
| Create Date |
May 10, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1055-2022 |
| Recall Event ID |
89881 |
| 510(K)Number |
K212656
|
| Product Classification |
Bronchoscope (flexible or rigid) - Product Code EOQ
|
| Product |
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) |
| Code Information |
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
UDI Code: 04048551225738
All Serial Numbers manufactured/distributed since January 2018 |
Recalling Firm/
Manufacturer |
Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
|
| For Additional Information Contact |
888-352-9616
|
Manufacturer Reason
for Recall |
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
On 04/01 and 6/2022, the firm emailed an "Urgent Medical Device Recall" letter to customers and followed up with a hardcopy letter on 04/07-08/2022 via their Third Party contractor informing customers of a labeling update to correct the instructions for use for certain flexible urological endoscopes and advise that high-level disinfection should not be used as a method of reprocessing. Supplemental validation testing of the efficacy of the manual high-level disinfection process using CIDEX OPA was performed. Testing showed that the required efficacy level of disinfection using CIDEX OPA was not achieved. To the extent included in the current applicable instructions for use, the following methods are being removed as reprocessing methods from the instructions for use of the affected endoscopes. +Manual High-Level Disinfection: -Cidex-OPA -Revital-Ox" RESERT¿ (e.g., 2.0% Accelerated Hydrogen Peroxide solution). +Automated Endoscope Reprocessor: -Medivators AER -Reliance EPS -EvoTech ECR Customer Actions: 1. Immediately discontinue the use of all high-level disinfection methods for reprocessing the affected endoscopes. 2. The affected endoscopes should be sterilized after each use by one of the sterilization methods recommended in the instructions for use specific to each endoscope. 3. If your facility does not have access to a sterilization method recommended in the applicable instructions for use, immediately discontinue use of the affected endoscopes and return products to KARL STORZ. 4. Ensure that all relevant personnel in your organization are aware of recall. 5. Updated instructions for use will be available at https://spwebspace.karlstorz.com/sites/HLDCorrection/SitePages/Home.aspx . Once the updated instructions for use are available, discard any prior versions of the instructions for use. Any questions: Telephone: 1-888-352-9616 Fax: 1-888-912-7088 E-Mail: karlstorz7041@sedgwick.com |
| Quantity in Commerce |
All Serial Numbers manufactured/distributed since January 2018 |
| Distribution |
U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = EOQ and Original Applicant = KARL STORZ Endoscopy America
|
