Recall Z-1429-2020 ยท FRW Scale, Patient
Seca
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
| Date | Jun 19, 2019 |
| Status | Open, Classified |
| Reason | 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 | 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 attachm |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.