ClearanceBrief
Recall Z-1232-04 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Boehringer Laboratories Inc

Boehringer Replacement Gauge Model 9071, Lot Number 200405.

DateJul 20, 2004 (initiated May 19, 2004)
StatusTerminated
ReasonThe suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
Root causeOther
ActionAll direct accounts were contacted by the recalling firm''s Customer Service Representative to determine the location of the affected product. The CSR arrange for replacement proudct.
Quantity9 units
DistributionThe recalled product was distributed to the following states: AL, FL, MA, MI, OR, PA, TN,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.