| Class 2 Device Recall Whatman Body Fluid Collection Paper 903 | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JKA
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