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U.S. Department of Health and Human Services

Class 2 Device Recall Whatman Body Fluid Collection Paper 903

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  Class 2 Device Recall Whatman Body Fluid Collection Paper 903 see related information
Date Initiated by Firm October 29, 2009
Date Posted September 07, 2010
Recall Status1 Terminated 3 on August 24, 2020
Recall Number Z-2384-2010
Recall Event ID 53819
510(K)Number K932661  
Product Classification tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534
903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790
Code Information Lot: W 071 6820708
Recalling Firm/
Manufacturer		 Whatman, Inc.
63 Community Drive
Sanford ME 04073
For Additional Information Contact SAME
207-459-7557
Manufacturer Reason
for Recall		 Neonate newborn screening card demographic and filter portion may be detached
FDA Determined
Cause 2		 Process control
Action The firm, Whatman, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 29, 2009, to the customer. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: inspect the card and ensure the 903 Paper Portion is firmly and completely fixed to the Demographic portio, prior to recording patient demographic details on the card and obtaining a patient sample; discard the card, obtain a new card and inspect as above, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card; and to please staple the card stub at two points as specified in the illustration, to prevent any opportunity for 903 paper detachment from the demographic portions. If Whatman customers/users have any questions in relation to this customer notification, please contact, either Product Manager at +1 732 885 6570,email: lili.lee@ge.com or Quality Assurance at +1 207 459 7557, email: heidi.kuell@ge.com.
Quantity in Commerce 488,000 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.
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