Recall Z-0806-2012 ยท FEQ Pump, Air, Non-Manual, For Endoscope
Olympus America Inc.
Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy
| Date | Jan 18, 2012 (initiated Dec 12, 2011) |
| Status | Terminated |
| Reason | Water may leak from the irrigation tubing used on the Olympus Flushing Pump |
| Root cause | Nonconforming Material/Component |
| Action | The firm,Olympus, sent an "URGENT-DEVICE CORRECTION " letter dated December 12, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that any current irrigation tubing in their inventory can be used with the OFP pump; however, they must inspect the tubing installed on the OFP pump for signs of water leakage; if leakage is found, discontinue use of the tubing and replace with a new irrigation tube. In addition, complete and return the enclosed questionnaire via fax to (484) 896-7128. If you do not wish to use your current inve |
| Quantity | 64,667 packages of 10 irrigation tubes |
| Distribution | Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, AND WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 Keymed (Medical & Industrial Equipment), Ltd., May 12, 2000 |