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Terminated

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

FDA Recall Z-2384-2010 · Posted 2010-09-07

Recalling FirmWhatman, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2009-10-29
Date Terminated2020-08-24
Product Quantity488,000 cards

Reason for Recall

Neonate newborn screening card demographic and filter portion may be detached

Firm 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: [email protected] or Quality Assurance at +1 207 459 7557, email: [email protected].

Root Cause

Process control

Distribution Pattern

Nationwide distribution: CA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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