Z-1429-2020Class II

Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009

Name: Z-1429-2020 Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
Creator: Seca
Published: 2019-06-19
License: https://open.fda.gov/license/

Seca / initiated 2019-06-19 / Open, Classified / root cause: manufacturing process

FDA source

Seca began a recall of Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009 on 2019-06-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1429-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-06-19
Posted: 2020-03-03
Recalling firm: Seca
Product: Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
Product code: FRW Scale, Patient
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.
Root cause tag: manufacturing process
FDA root 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 [email protected] 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 [email protected] 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
Product codes and lots: serial numbers: 6002142000002 - 6002142001101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1429-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1429-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-03-11	2020-03-03

Product code FRW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)