ClearanceBrief
Recall Z-0415-05 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)

S S C O R Inc

SSCOR Suction Device Model 2314B

DateJan 27, 2005 (initiated Jan 6, 2005)
StatusTerminated
ReasonReports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
Root causeOther
ActionSSCOR Powered Suction Device not performing as intended.
Quantity196
DistributionCA, FL, IA, IL, IN, KY, MO, NC, NJ, NY, OH, France, New Zealand, Singapore, United Kingdom
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.