Class 2 Device Recall Seca 402/403 cart

• Date Initiated by Firm: June 19, 2019
• Create Date: March 03, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1429-2020
• Recall Event ID: 84817
• Product Classification: Scale, patient - Product Code FRW
• Product: Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
• Code Information: serial numbers: 6002142000002 - 6002142001101
• Recalling Firm/ Manufacturer: Seca; Hammer Steindamm 9-25; Hamburg Germany
• For Additional Information Contact: jeffrey c mayes ; 800-5427322
• Manufacturer Reason for Recall: It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling from the cart. If a baby is left unattended in a cart, the baby could fall off the scale and be subjected to several serious injuries.
• FDA Determined Cause: Process design
• Action: On June 19, 2019 a "Urgent: Correction/recall of seca 402/403 - Cart for seca baby scale" was mailed to customers. The letter provided details on the recall product and asked customers to do the following: End Users: Immediate Measures to Take: " With the appropriate Allen wrench, re-tighten all the screw connections as firmly as possible (see attachment 1). " Apply the brakes on both wheels. " Mark the baby scale cart with the warning label (see attachment 2) " Do not make mobile use of the cart, use it only at one fixed location. " Please confirm receipt of this notice by completing attachment 3, scanning the attachment, and returning it to seca by e-mail to babyscalecart.us@seca.com within one week of receipt of this information " Wait for further information about Upgrade Kit to replace the affected wheels (see section Upgrade Kits). DISTRIBUTORS: Immediate Measures to Take " Please stop the delivery of the baby scale carts right away. " If you have any carts in stock, quarantine the carts by placing them in one specific location. " Wait for further information about Upgrade Kit to replace the affected wheels. (see section Upgrade Kits). " Please IMMEDIATELY forward a of the Urgent Correction/Recall of seca 402/403 for end users to your end users (attached to this letter). seca will be reaching out to all distributors and end users directly, out of overabundance of caution. Therefore, please identify the customers who have purchased seca 402/403 and send us the customer list within one week of receipt of this information. The list shall include name and address of the customers, number of the purchased carts and their serial numbers, names of contact persons, and their email addresses. " Please confirm receipt of this Correction/Recall notice by scanning and returning to us the response form in attachment 2 by e-mail to babyscalecart.us@seca.com within one week of receipt of this information. Upgrade Kits: Seca is already working
• Quantity in Commerce: 254 scale carts
• Distribution: US: CA, MI, WA, WV, VA, NM, LA, TN, IL, PA, OH, FL, WA, OR, NY, CO, IA, MN, TX, MA, NC, LA, KY, NM AL,DC, NJ, AK, AZ, NV, SC, HI, MD, WI, RI, DE, MO OUS: Canada
• 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.