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U.S. Department of Health and Human Services

Class 2 Device Recall Naera Hospital Bassinet

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Naera Hospital Bassinet see related information
Date Initiated by Firm October 10, 2018
Create Date February 07, 2019
Recall Status1 Open3, Classified
Recall Number Z-0813-2019
Recall Event ID 81393
Product Classification Bassinet, hospital - Product Code NZG
Product Naera Hospital Bassinet, Model No. 4402
Code Information 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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 2
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 5869
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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