Recall Z-2384-2010 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Whatman, Inc.
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
| Date | Sep 7, 2010 (initiated Oct 29, 2009) |
| Status | Terminated |
| Reason | Neonate newborn screening card demographic and filter portion may be detached |
| 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 car |
| Quantity | 488,000 cards |
| Distribution | Nationwide distribution: CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932661 | WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 Whatman Specialty Products, Inc., Apr 17, 1996 |