| Class 2 Device Recall Fernotrac | |
Date Initiated by Firm | March 10, 2016 |
Create Date | May 04, 2016 |
Recall Status1 |
Terminated 3 on August 23, 2016 |
Recall Number | Z-1604-2016 |
Recall Event ID |
73641 |
Product Classification |
Stretcher, patient restraint - Product Code NZD
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Product | Poly-bags containing the strap labeled with "Adult" 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 Adult Model 444 |
Recalling Firm/ Manufacturer |
Ferno-Washington Inc 70 Weil Way Wilmington OH 45177-9371
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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 conta |
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 | 270 |
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 |
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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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