Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.
FDA Recall Z-1871-2009 · Posted 2009-09-30
Advertisement
Recalling FirmWhatman, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2009-05-06
Date Terminated2011-10-25
Product Quantity2,853,410 cards
Reason for Recall
The two portions of the card are coming apart prematurely.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement