Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals in the collection and in-vitro st
FDA device recall Z-1871-2009 · posted 2009-09-30 · Terminated
Recall details
- Recalling firm
- Whatman, Inc.
- Reason for recall
- The two portions of the card are coming apart prematurely.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 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.
- Date initiated
- 2009-05-06
- Date posted
- 2009-09-30
- Date terminated
- 2011-10-25
- Location
- Sanford, ME
Monitor recalls programmatically
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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 |