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U.S. Department of Health and Human Services

Class 2 Device Recall DocUDose

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  Class 2 Device Recall DocUDose see related information
Date Initiated by Firm August 02, 2006
Date Posted October 19, 2006
Recall Status1 Terminated 3 on May 21, 2012
Recall Number Z-0045-2007
Recall Event ID 36103
Product Classification Medication reminder - Product Code NXQ
Product Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime.''
Code Information Four (4) lot codes are subject to recall: 312733, 312734, 313767, and 313768. This accounts for all of the Doc-U-Dose packets distributed by the firm since May 13, 2006.
Recalling Firm/
Manufacturer		 Eatonform Inc
2280 Arbor Blvd
Dayton OH 45439-1522
For Additional Information Contact S. Doyle Key
800-338-2012
Manufacturer Reason
for Recall		 Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.
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 8/2/2006, 8/4/2006, and 8/11/2006. In their recall notifications, the firm requested that the pharmacy customers: 1) cease using and distributing all Doc-U-Dose packets identified with the recalled lot numbers; 2) segregate and secure all Doc-U-Dose packets identified with the suspect lot numbers on-hand; 3) inform the firm as to whether or not they have any of the suspect product which they would be returning and the quantity of product to be returned; 4) return all packets to Eatonform at the recalling firm¿s expense; and 5) notify their subaccount customers and ask that they cease using the device until such time as the problem is corrected.
Quantity in Commerce approximately 913 cartons
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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