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 3 Device Recall Active Life Little Ones OnePiece Custom Urostomy Pouch 5/16 1 inch, 825mm

  • 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 3 Device Recall Active Life Little Ones OnePiece Custom Urostomy Pouch 5/16 1 inch, 825mmsee related information
Date Initiated by FirmFebruary 14, 2008
Date PostedMay 07, 2008
Recall Status1 Terminated 3 on October 21, 2008
Recall NumberZ-1179-2008
Recall Event ID 46802
Product Classification Ostomy pouch and accessories - Product Code EXB
ProductActive Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558
Code Information Lot Numbers: 6G4890N, 7C0178N, 7D0529N, 7E1100N, 7F1816N, 7F2009N, 6B2462N, 6E3474N, 6H5767N, 6J5972N and 6L7175N. UPC Code: 30003-020917.
Recalling Firm/
Manufacturer		 ConvaTec
200 Headquarters Park Dr
Skillman NJ 08558-2624
For Additional Information ContactKaren Krenta
732-904-2071
Manufacturer Reason
for Recall		Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.
FDA Determined
Cause 2		Labeling mix-ups
ActionConsignees were notified by an Urgent Product Recall Letter on 2/14/08. Updated letters were issued on 2/21/08 and 4/10/08 with expanded lot numbers. The letters instruct users to return any affected products and a product recall response form. For additional information, contact (908) 904-2199.
Quantity in Commerce3986 market units
DistributionNationwide Distribution.
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.
-
-