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U.S. Department of Health and Human Services

Class 2 Device Recall Fernotrac

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  Class 2 Device Recall Fernotrac see related information
Date Initiated by Firm March 10, 2016
Create Date May 04, 2016
Recall Status1 Terminated 3 on August 23, 2016
Recall Number Z-1603-2016
Recall Event ID 73641
Product Classification Stretcher, patient restraint - Product Code NZD
Product Poly-bags containing splint strap labeled with "Pediatric" sticker.

Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
Code Information Strap Kit Pediatric Model 443 
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177-9371
For Additional Information Contact Dorthy A. Ramsery
937-283-2885
Manufacturer Reason
for Recall		 On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled pediatric cont
FDA Determined
Cause 2		 Process control
Action Ferno-Washington, Inc , has contacted all customers via telephone on March 10, 2016. All products will be replaced with new products. For further questions, please call: (937) 283-2885.
Quantity in Commerce 153
Distribution Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..
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.
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