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U.S. Department of Health and Human Services

Class 2 Device Recall Ferno PROFlexx Model 28Z Chair Cot

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 Class 2 Device Recall Ferno PROFlexx Model 28Z Chair Cotsee related information
Date Initiated by FirmMarch 08, 2017
Date PostedApril 15, 2017
Recall Status1 Terminated 3 on June 29, 2017
Recall NumberZ-1827-2017
Recall Event ID 76765
Product Classification Stretcher, wheeled - Product Code FPO
ProductFerno PROFlexx Model 28Z Chair Cot
Code Information 17E003185, 17E003169, 17E003179, 17E003180, 17E003181, 17E003183, 17E003187, 17E003152, 17E003168, 17E003171, 17E003172, 17E003173, 17E003184, 17E003170, 17E003138, 17E003139, 17E003140, 17E003141, 17E003153, 17E003154, 17E003155, 17E003156, 17E003157, 17E003158, 17E003159, 17E003160, 17E003161, 17E003162, 17E003163, 17E003164, 17E003165, 17E003166, 17E003167, 17E003174
FEI Number 1523574
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177-9371
For Additional Information ContactDorothy A. Ramsey
937-283-2885
Manufacturer Reason
for Recall		The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionConsignees were contacted via telephone and email on 3/8/17. No product will be returned to the recalling firm. The firm and its service company will correct each product in the field at the customers location.
Quantity in Commerce34 units
DistributionWorldwide distribution. The recalled products were distributed to the following states: CA, FL, HI, IL, NY, OH. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall. The recalled product was distributed to the following countries: Taiwan, United Arab Emirates, Thailand, Singapore
Total Product Life CycleTPLC 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.
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