Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M recall: Sterility Concern
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130…
Why was Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M recalled?
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 711,157 units units
- Distribution
- Nationwide
- Recall date
- September 15, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)