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U.S. Department of Health and Human Services

Class 2 Device Recall DocUDose Prescription Management System, Item 8PKIT

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  Class 2 Device Recall DocUDose Prescription Management System, Item 8PKIT see related information
Date Initiated by Firm September 28, 2006
Date Posted November 16, 2006
Recall Status1 Terminated 3 on May 21, 2012
Recall Number Z-0189-2007
Recall Event ID 36531
Product Classification Prescription Management System - Product Code NQX
Product Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton.
Code Information Carton numbers: 16 through 39 were subject to recall.
Recalling Firm/
Manufacturer		 Eatonform Inc
2280 Arbor Blvd
Dayton OH 45439-1522
For Additional Information Contact
937-298-3408
Manufacturer Reason
for Recall		 The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers.
FDA Determined
Cause 2		 Other
Action The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 9/28/2006. In their recall notification, the firm requests that the customers: 1) Cease using and distributing all Doc-U-Dose packets identified with the recalled carton numbers [instructions are provided as to how to identify the carton number]; 2) Segregate and secure all Doc-U-Dose packets identified with the suspect carton numbers [16 - 39 inclusive] or any packets from open cartons bearing those numbers; 3) Complete the attached Recall Verification Form which requests information concerning whether or not the customer(s) have any of the suspect product which they will be returning and the quantity of product to be returned; and provide the signature, title, and date of completion of the form by the individual responsible for carrying out the recall action [According to the recalling firm's instructions, the Verification Form is to be returned to Eatonform by fax or E-mail , no later than 3 business days following the receipt of the recall notification. Lastly, a toll-free no. is provided and the customer(s) is asked to call the firm's Packet Return Center and obtain instructions for returning any of the packets found on-hand [at the recalling firm's expense] and to return all packets to Eatonform as instructed.
Quantity in Commerce 24 cartons [24,000 sets of four packets each]
Distribution Nationwide.
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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