Recall Z-0229-2025
Olympus Corporation of the Americas · initiated August 23, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Codes / lots: UDI-DI: 15019778003191; Serial Numbers: 22324681 22324838 22324815 22324817 22324668 22324816 22324667 22324666 22324837 22325205 22325319 22325320 22325005 22324922 22325318 22325008 22324932 22325207 22324931 22325306 22325593 22325317 22325208 22325315 22325316 22325409 22325411 22325305 22325304 22325408 22325410 22324923 22325303 22325592 22325579 22326433 22325665 22326420 22326435 22326299 22325582 22325594 22326281 22324536 22326418 22326419 22325580 22325595 22325651 22326417 22325650 22326434 22326436 22325649 22326495 22325581 22326284 22326283 22325583 22326309 22326308 22326282 22326892 22326891 22326503 22326599 22326895 22326597 22326897 22326608 22326506 22326894 22326598 22326496 22327325 22327322 22326607 22326497 22327327 22326600 22327323 22326505 22329514 22329504 22329332 22329506 22329503 22329507 22329497 22329467 22329513 22329341 22329343 22329331 22329751 22329596 22329752 22329605 22329608 22329753 22329610 22331369 22331173 22331037 22331153 22331035 22331156 22331341 22331342 22331362 22331343 22331155 22331172 22326893 22331152 22331904 22331903 22331458 22331556 22331561 22331546 22331558 22331461 22331460 22331459 22331457 22331477 22331345…
Reason for recall
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
FDA-determined cause: Equipment maintenance
Action taken
An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 9/20/24 was sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. The range of affected serial numbers is included at the top of this letter. The serial number is on a label affixed to the back of the OFP-2 pump. An Olympus representative will create a Return Material Authorization for the return of your device to Olympus for an inspection. You may continue to use your OFP-2 pump until an Olympus representative performs the inspection. If the OFP-2 fails the inspection, the OFP-2 will require repair. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0455 c. Complete the form as instructed. 3. If you have further distributed this product, identify your customers, and forward them this notification. 4. Beginning November 2024, please contact Olympus Customer Service at 1-800-848-9024, option 3, to request an Air Switch Assembly Inspection . Olympus will arrange for the return of your device to our Olympus Repair Center at a mutually convenient time. The Olympus representative s record of repair will also serve as the completion record of this action for your facility. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
Details
- Recall number
- Z-0229-2025
- Initiated
- August 23, 2024
- Posted by FDA
- October 25, 2024
- Product code
- FEQ – Pump, Air, Non-Manual, For Endoscope
- Quantity
- 445 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA