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FDA (Device enforcement)Recalled 2022-09-01class ii

Johnson & Johnson Surgical Vision, Inc.: Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

Hazard

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

Details from the source

Reason for recall: As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue. Distribution: Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwait, Morocco, Netherlands, New Zealand, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, S Quantity: 53,624 units Lot/code info: Part Number: VRT-AI UDI-DI Code: 05050474700901 Lot Numbers: 60316112 60330206 60330248 60341105 60341106 60341107 60342401 60343412 60343413 60351691 60352993 60352994 60352995 60352996 60352997 60352998 60352999 60353436 60353443 60353444 60353445 60353446 60353447 60353448 60353449 60353450 60353451 60353452 60353453 60353772 60353811 60353812 60353813 60353814 60353815 60354982 60355023 60355024 60355025 60355026 60355027 60355330 60355335 60355972 60360065 60360066 60362043 60362044 60362435 60362436 60364566 60369607 60369608 60369609 60381689

UPC codes

05050474700901

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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