510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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Z-1473-2024Class II

Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

Karl Storz Endoscopy-America, Inc. / initiated 2024-02-27 / Open, Classified
FDA source (opens on fda.gov)

Karl Storz Endoscopy began a recall of Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE on . FDA classified it as Class II and gives the reason as "Inadequate reprocessing validation evidence". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1473-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Karl Storz Endoscopy-America, Inc.
Product
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Product code
HET Laparoscope, Gynecologic (And Accessories)
Reason for recall
Inadequate reprocessing validation evidence
FDA root cause
Under Investigation by firm
Action
On March 4, 2024, Karl Storz issued a "Urgent: Medical Device Recall" via UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of associated part numbers listed. 2. Pass on this Urgent Medical Device Recall Notice to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. 3. If you have or may have distributed the products listed, please identify and promptly notify those recipients, or provide KARL STORZ a list of customers who received/may have received the products listed. 4. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5. Contact your KARL STORZ representative or call KARL STORZ Customer Support to return affected products. For Human Product: 5a. Call Customer Support at 800-421-0837 Option 1 to set up an RMA. 5b. Or call your KARL STORZ representative to assist with setting up an RMA. For Veterinary Product: 5c. Call KSVEA Customer Support at 800-955-7832 Option 1 to set up an RMA. 5d. Or email [email protected] 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.
Quantity in commerce
27 units
Distribution
US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
Product codes and lots
UDI: 04048551259788/ All Lots

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1473-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1472-2024Class IIOngoingVoluntary: Firm initiated
Z-1473-2024Class IIOngoingVoluntary: Firm initiated
Z-1474-2024Class IIOngoingVoluntary: Firm initiated