Recall Z-0813-2019 ยท NZG Bassinet, Hospital
Stryker Medical Division of Stryker Corporation
Naera Hospital Bassinet, Model No. 4402
| Date | Feb 7, 2019 (initiated Oct 10, 2018) |
| Status | Terminated |
| Reason | It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses i |
| Root cause | Device Design |
| Action | The firm notified customers on October 10, 2018, via Urgent Medical Device Recall letters. The letters informed users of the issue with the mattress component of the bassinet. Customers were instructed to do the following: 1. Find the serial numbers listed on the attached business reply form and be sure you know where they are located at your facility. 2. Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email productfieldaction@stryker.com. 3. Inspect the Nra bassinets at your location. If any exhibit the condition as shown in the Produc |
| Quantity | 5915 |
| Distribution | Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.