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U.S. Department of Health and Human Services

Class 2 Device Recall Irrigation Tubing for KARL STORZ Endomat Select UP210

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 Class 2 Device Recall Irrigation Tubing for KARL STORZ Endomat Select UP210see related information
Date Initiated by FirmOctober 21, 2024
Date PostedNovember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0363-2025
Recall Event ID 95607
Product Classification Tubing and tubing/filter fits - Product Code NVT
ProductIrrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Code Information Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222
FEI Number 3007475226
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information ContactMrs. Kathy Strange
774-284-1736
Manufacturer Reason
for Recall		Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
FDA Determined
Cause 2		Labeling design
ActionOn 10/22/2024, an "URGENT: MEDICAL DEVICE CORRECTION" Letters will be sent via email by KARL STORZ informing customers that the firm has become aware that one lot number of misbranded product was distributed to 19 customers. Customers are instructed to: 1. Pass on this Urgent Medical Device Correction to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. 2. Communicate to all applicable users that the product is not to be utilized during spinal procedures. 3. If you have or may have distributed the products listed, please identify and promptly notify those recipients of this notice. 4. Return the completed Customer Reply Form by E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5. 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. for questions send an email to KSEAProductLabeling@karlstorz.com .
Quantity in Commerce40 units
DistributionU.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
Total Product Life CycleTPLC 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.
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