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Showing 7821–7840 of 8393 results

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Cardinal Health 200, LLC: Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolat...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health ...

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

FDAJan 7, 2021Nationwide• Cardinal Health 200, LLC

Baxter Healthcare Corporation: Infusion Pump

Battery performance issues related to prolonged storage.

FDAJan 6, 2021AL, AK, AZ +49 more• Baxter Healthcare Corporation

Respironics California, LLC: PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(...

Due to unqualified "design verification" batteries being shipped to customers.

FDAJan 6, 2021Nationwide• Respironics California, LLC

Baxter Healthcare Corporation: Gambro Cartridge Low Volume Blood Transport System for He...

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Low Weight-Low Volume Blood Transport Sy...

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Single Needle Conversion Kit, product co...

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Blood Transport System for Hemodialysis ...

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Blood Set Prime Line, product code 10102...

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

New Standard Device Inc: Metalogix Self-Drill Half-Pin, a component of the Revolut...

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

FDADec 28, 2020AZ, GA, IL +8 more• New Standard Device Inc

Baxter Healthcare Corporation: FLOW COUPLER Monitor Flow Coupler devices are sold in 5 s...

Potential for the battery to lose its ability to be recharged.

FDADec 28, 2020Nationwide• Baxter Healthcare Corporation

Philips North America: PHILIPS Incisive Computed tomography X-ray system Incisiv...

Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured

FDADec 24, 2020Nationwide• Philips North America

Tenderneeds Fertility LLC: Pro Series Fertility Device (SKU 644042788139)

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Deluxe At Home Artificial Insemination Kit (SKU 636391205...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Professional Clinical Artificial Intrauterine Inseminatio...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Ultimate Fertility At Home Insemination Kit with Sperm Wa...

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Deluxe At Home Pro Series Insemination Kit (SKU 644042787...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Premium At Home Pro Series Insemination Kit (SKU 64404278...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Professional At Home Artificial Intrauterine Insemination...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Home Artificial Insemination Kit Human IUI ICI Pregnancy ...

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

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