4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5

FDA device recall Z-0526-2025 · posted 2024-11-25 · Open, Classified

Recall details

Recalling firm

Karl Storz Endoscopy

Reason for recall

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

Action taken

On 10/28/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS ground through a third party company (Sedgwick) to customers informing them that KARL STORZ has discovered a compromised sterile barrier during a visual inspection. Customers are instructed to: 1.Immediately quarantine and discontinue use of associated material numbers and associated lot numbers listed. 2.Pass on this Urgent Medical Device Recall 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: " Call Customer Support at 800-421-0837 Option 1 to set up an RMA. " Or call your KARL STORZ representative to assist with setting up an RMA. For Veterinary Product: " Call KSVEA Customer Support at 800-955-7832 Option 1 to set up an RMA. " Or email VetCustomerService@karlstorz.com 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. If you have product to return, please contact KARL STORZ to set up an RMA. For Human Product Telephone: 800-421-0837 Option 1 For Vet Product Telephone: 800-955-7832 Option 1 For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HRX

Quantity affected

105 devices

Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.

Date initiated

2024-10-11

Date posted

2024-11-25

Location

El Segundo, CA

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