Z-2384-2010

Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended...

Name: Z-2384-2010 Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended...
Creator: Whatman, Inc.
Published: 2009-10-29
License: https://open.fda.gov/license/

Whatman, Inc. / initiated 2009-10-29 / Terminated / root cause: manufacturing process

FDA source

Whatman, Inc. began a recall of Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the... on 2009-10-29. The reason FDA records is "Neonate newborn screening card demographic and filter portion may be detached". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2384-2010
Status: Terminated
Initiated: 2009-10-29
Posted: 2010-09-07
Terminated: 2020-08-24
Recalling firm: Whatman, Inc.
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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Neonate newborn screening card demographic and filter portion may be detached
Root cause tag: manufacturing process
FDA root cause: 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: [email protected] or Quality Assurance at +1 207 459 7557, email: [email protected].
Quantity in commerce: 488,000 cards
Distribution: Nationwide distribution: CA
Product codes and lots: Lot: W 071 6820708

Product code JKA

K932661Class IIWhatman Body Fluid Collection Paper:whatman Bfc180Whatman Specialty Products, Inc. / cleared 1996-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)