Class 2 Device Recall Naera Hospital Bassinet

• Date Initiated by Firm: October 10, 2018
• Date Posted: February 07, 2019
• Recall Status: Terminated on April 29, 2020
• Recall Number: Z-0813-2019
• Recall Event ID: 81393
• Product Classification: Bassinet, hospital - Product Code NZG
• Product: Naera Hospital Bassinet, Model No. 4402
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2018000700023 2018000700024 2018000700025 2018000700026 2018000700027 2018000700028 2018000700029 2018000700030 2018000700031 2018000700032 2018000700033 2018000700034 2018000700035 2018000700037 2018000700038 2018000700039 2018000700040 2018000700041 2018000700042 2018000700043 2018000700044 2018000700045 2018000700046 2018000700048 2018000700049 2018000700051 2018000700052 2018000700053 2018000700054 2018000700055 2018000700058 2018000700059 2018000700060 2018000700061 2018000700062 2018000700063 2018000700064 2018000700065 2018000700066 2018000700067 2018000700068 2018000700069 2018000700070 2018000700071 2018000700072 2018000700073 2018000700074 2018000700075 ***added 5/13/19*** 2018000602521 2018000602522 2018000602523 2018000602524 2018000602525 2018000602526 2018000602527 2018000602528 2018000602529 2018000602530 2018000602531 2018000602532 2018000602533 2018000602534 2018000602535 2018000602536 2018000602537 2018000602538 2018000602539 2018000602540 2018000602541 2018000602542 2018000602543 2018000602544 2018000602545 2018000602546 2018000602547 2018000602548 2018000602549 2018000602550 2018000602551 2018000602552 2018000602553 2018000602554 2018000602555 2018000602556 2018000602557 2018000602558 2018000602559 2018000602560 2018000602561 2018000602562 2018000602563 2018000602564 2018000602565 ***Updated 9/9/19*** 2017000600882
• Recalling Firm/ Manufacturer: Stryker Medical Division of Stryker Corporation; 3800 E Centre Ave; Portage MI 49002-5826
• For Additional Information Contact: Ms. Victoria Haney; 269-389-8306
• Manufacturer Reason for Recall: 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 in the field.
• FDA Determined 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 N¿ra bassinets at your location. If any exhibit the condition as shown in the Product issue section of this letter, please quarantine the unit, remove it from service, and contact Stryker at 269 389 8306. 4. One of Strykers representatives will contact you to schedule the replacement of the mattresses in all affected units at your location. 5. If you have questions regarding the continued safe use of your product, please contact Technical Support by calling +1 800 327 0770 and selecting opt 2. 6. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 7. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. If you have any questions or concerns, please contact Customer Service +1 800 327 0770. The firm's normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).
• Quantity in Commerce: 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.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.