—#188198

Product

Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

FDA product code: FED — Endoscopic Access Overtube, Gastroenterology-Urology
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K151801
Affected lot / code info: Lot numbers: 60780 62151 64141 65464 66365 60862 62405 64263 65465 66367 60865 62407 64265 65466 66634 60867 62469 64268 65489 66636 60869 62471 64533 65490 66638 61168 62473 64535 65491 66640 61171 62781 64537 65496 66910 61176 62783 64674 65497 66912 61285 62787 64676 65498 66914 61578 63035 64678 65499 67021 61580 63037 64738 65521 67023 61582 63039 64831 65523 67025 61662 63310 64844 65525 69148 61664 63314 65173 65527 69150 62007 63316 65340 66017 69260 62009 63582 65342 66019 69554 62011 63584 65344 66021 69556 62013 63586 65390 66023 69774 62146 64132 65391 66361 69776 62149 64134 65392 66363

Why it was recalled

Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Olympus Own Label Distributor US issued letter 8/3/21 via UPS Ground, letter states reason for recall, health risk and action to take: Olympus requires you to take the following immediate action: 1. Carefully read the content of this Field Safety Notice. 2. Below are examples of a gap in the seal between the lid and the plastic package 3. As per the instructions for use, do not use if packaging is damaged. If you observe this packaging anomaly or any other damage to the packaging, immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 4. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0399 and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this Field Safety Notice, and appropriately document your notification process. Please do not hesitate to contact me directly at 484-896-5688 or at email laura.storms@olympus.com for any additional information concerning this matter

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2021-08-03
Terminated: 2023-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.