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Showing 7981–8000 of 11714 results

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Vanta Clinician Programmer (Medtronic) – Software Anomalies (2022)

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

FDADec 3, 2022Nationwide• Medtronic Neuromodulation

Surgipro Polypropylene Sutures (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Custom Suture Pack (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Moderate

FDADec 2, 2022Nationwide

Sofsilk Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Monosof Nylon Sutures (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Novafil Polybutester Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Medical Cutting Needle (Remington) – Incorrect Stylet Length (2022)

The stylet is longer than specified on the label

FDADec 2, 2022AL, CA, NC +3 more• Remington Medical, Inc.

Ti-Cron Polyester Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Nylon Suture (McKesson) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Surgilon Nylon Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Lamaze Chill Teether (Tomy) – Microbial Growth Risk (2022)

Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.

FDADec 2, 2022Nationwide• Tomy International Inc.

Codman Surgical Patties (Integra) – Endotoxin Issue (2022)

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

FDADec 2, 2022Nationwide• Integra LifeSciences Corp.

Surgidac Polyester Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Dermalon Nylon Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

Surgipro II Polypropylene Sutures (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

EdgeAhead Stiletto Knife (Beaver Visitec) – Packaging Sterility (2022)

Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

FDANov 30, 2022Nationwide• Beaver Visitec International, Inc.

Source Administration Set (Bayer) – Black Specks on Needles (2022)

Black specks may be present on the packaged needles

FDANov 30, 2022Nationwide• Bayer Medical Care, Inc.

Dual-Trak Clavicle Screws (Acumed) – Pre-Market Clearance Issue (2022)

Distribution without Pre-Market Clearance

FDANov 29, 2022Nationwide• Acumed LLC

AcuTwist Compression Screws (Acumed) – Pre-Market Clearance Issue (2022)

Distribution without Pre-Market Clearance

FDANov 29, 2022Nationwide• Acumed LLC

HeartWare Model 1100 (Heartware) – Driveline Cover Hardening (2022)

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

FDANov 29, 2022Nationwide• Heartware, Inc.

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