Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

FDA device recall Z-1320-2023 · posted 2023-04-01 · Open, Classified

Recall details

Recalling firm

Biosense Webster, Inc.

Reason for recall

Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

Action taken

On March 2, 2023, Biosense Webster, Inc. issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" notification to affected US customers via FedEx. The notification was issued to foreign consignees on February 29, 2023. In addition to informing consignees about the recall Biosense Webster asked customer to take the following actions: 1. Carefully review the information contained in this Medical Device Correction/Removal. 2. Ensure that anyone in your facility who needs to be aware of this notification reads the attached letter carefully. 3. Evaluate if you have inventory of CARTO VIZIGO" Bi-Directional Guiding Sheath (Catalog Numbers: D-1385-01-S and D-1385-02-S) Lot Numbers 00002137 and 50000224 and segregate the product. For assistance in identifying impacted product, please reference ATTACHMENT 1: PRODUCT IDENTIFICATION TOOL. 4. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. 5. If you have inventory affected by this action: 5.1. Return inventory to Sedgwick using the enclosed return label. 5.2. Complete and sign the Business Response Form 5.3. Scan the signed completed form and email it to: BWI7774@sedgwick.com or Fax it to 888-877-7241. Subject: Attention: BWI Field Action Event #7774 6. If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this to the relevant personnel. 7. Maintain a copy of this communication where the product identified in this letter is located until all products have been destroyed.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DYB

Quantity affected

316 units

Distribution

Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN,

Date initiated

2023-02-21

Date posted

2023-04-01

Location

Irvine, CA

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