Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by h
FDA device recall Z-2384-2010 · posted 2010-09-07 · Terminated
Recall details
- Recalling firm
- Whatman, Inc.
- Reason for recall
- Neonate newborn screening card demographic and filter portion may be detached
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 488,000 cards
- Distribution
- Nationwide distribution: CA
- Date initiated
- 2009-10-29
- Date posted
- 2010-09-07
- Date terminated
- 2020-08-24
- Location
- Sanford, ME
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (K932661) | Whatman Specialty Products, Inc. | 1996-04-17 |