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U.S. Department of Health and Human Services

Class 3 Device Recall Body Fluid Collection Paper

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  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/
Whatman, Inc.
63 Community Drive
Sanford ME 04073
For Additional Information Contact
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.