notyard
04-15-2009, 08:36 AM
FDA class II recall--snipped to fit under 10K post character limit:
PRODUCT
Meter Remote for OneTouch Ping Glucose Management System. Recall # Z-0955-2009
CODE
Serial numbers: AAXNN080, AAXND08J, AAXNC00X, AAXNN06Q, AAXNP09T, AAXNK07H, AAXND00C...SNIP...AAXNH07B, AAXMQ00L, AAXNK0CS, AAXNG03C, AAXPR05F, AAXPR087, AAXNV014, AAXPR08B, AAXNJ051, AAXNF04C, AAXPR071, AAXMQ004, and AAXNG07Z.
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letters dated October 27, 2008 and November 18, 2008. Firm initiated recall is ongoing.
REASON
Incorrect dosing recommendation.
VOLUME OF PRODUCT IN COMMERCE
5,093 units
DISTRIBUTION
Nationwide
PRODUCT
Meter Remote for OneTouch Ping Glucose Management System. Recall # Z-0955-2009
CODE
Serial numbers: AAXNN080, AAXND08J, AAXNC00X, AAXNN06Q, AAXNP09T, AAXNK07H, AAXND00C...SNIP...AAXNH07B, AAXMQ00L, AAXNK0CS, AAXNG03C, AAXPR05F, AAXPR087, AAXNV014, AAXPR08B, AAXNJ051, AAXNF04C, AAXPR071, AAXMQ004, and AAXNG07Z.
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letters dated October 27, 2008 and November 18, 2008. Firm initiated recall is ongoing.
REASON
Incorrect dosing recommendation.
VOLUME OF PRODUCT IN COMMERCE
5,093 units
DISTRIBUTION
Nationwide