Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Orajel

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Orajelsee related information
Date Initiated by FirmJune 09, 2005
Date PostedAugust 03, 2005
Recall Status1 Terminated 3 on December 11, 2007
Recall NumberZ-1082-05
Recall Event ID 32593
Product Classification Toothbrush, Manual - Product Code EFW
ProductOrajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553
Code Information Model 7531, barcode # 3 10310 32362 2 (This product does not have lot numbers assigned).
Recalling Firm/
Manufacturer		 Del Laboratories Inc.
55 West Ames Court
Suite 100
Plainview NY 11803
For Additional Information ContactBruce J. MacKay, PhD
516-349-2520
Manufacturer Reason
for Recall		Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.
FDA Determined
Cause 2		Other
ActionRecall letters were sent on 6/09/05 by FedEx to direct wholesalers/distributors and retailers nationwide. A nationwide press release was issued on 6/10/05, and notification sent to numerous consumer & parenting publications, plus posting on company website. Questions from consumers should be referred to Del Pharmaceuticals at 1-800-818-1915 or by email at consumer_relations@orajel.com. Recall letters were sent to 3 direct accounts on 7/21/05 via FedEx after the discovery that these accounts had not been notified.
Quantity in Commerce134,082 units domestically, and 1578 units internationally as samples
DistributionNationwide & Puerto Rico.
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.
-
-