Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for us

FDA device recall Z-0806-2012 · posted 2012-01-18 · Terminated

Recall details

Recalling firm

Olympus America Inc.

Reason for recall

Water may leak from the irrigation tubing used on the Olympus Flushing Pump

Action taken

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 inventory of irrigation tubing and would like a replacement, call Olympus Customer Care Center at 1-800-848-9024. Olympus is discontinuing the current version of irrigation tubing and has redesigned the irrigation tubing to prevent water leakage. For any additional information, contact the V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or email at laura.storms-tyler@olympus.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FEQ

Quantity affected

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

Date initiated

2011-12-12

Date posted

2012-01-18

Date terminated

2012-09-25

Location

Center Valley, PA

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