Recall Z-1871-2009 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Whatman, Inc.
Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.
| Date | Sep 30, 2009 (initiated May 6, 2009) |
| Status | Terminated |
| Reason | The two portions of the card are coming apart prematurely. |
| Root cause | Process control |
| Action | Whatman issued an Urgent Medical Device Correction letter to to the direct account on 5/6/09 requesting this notice is distributed to users. The notice states the safety issue; requests users to inspect 903 cards prior to use, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card, discard the card obtain a new card and inspect. On May 26, 2009 the firm expanded the notification to additional users of the 903 cards to inspect cards prior to use. |
| Quantity | 2,853,410 cards |
| Distribution | Nationwide Distribution -- AZ, FL, GA, NC, IL, IN, LA, KS, KY, MI, MO, NE, NY, OH, OK, PA, SC, OR, TX, TN,UT VA, WI, WI, & PR. |
| 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 |