• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Body Fluid Collection Paper

  • 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 Body Fluid Collection Paper see related information
Date Initiated by Firm May 19, 2009
Date Posted March 05, 2010
Recall Status1 Terminated 3 on September 28, 2015
Recall Number Z-1005-2010
Recall Event ID 52101
510(K)Number K932661  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ.

The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.

Code Information Lot Number: W071, Job Numbers: 6797908 and 6820708.
Recalling Firm/
Manufacturer
Whatman, Inc.
63 Community Drive
Sanford ME 04073
For Additional Information Contact
207-459-7557
Manufacturer Reason
for Recall
'903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results
FDA Determined
Cause 2
Process control
Action Whatman issued an "Urgent Medical Device Correction " letter on May 19, 2009. The consignee was instructed to remove cards with duplicate numbers. For further information, contact Whatman Inc. Quality Assurance at 1-207-459-7557.
Quantity in Commerce 11,300 Cards
Distribution Nationwide Distribution -- CA.
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.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = WHATMAN SPECIALTY PRODUCTS, INC.
-
-