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Showing 10581–10600 of 11714 results

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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: Infusion Pump

Battery performance issues related to prolonged storage.

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

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJan 4, 2021Nationwide• Nostrum Laboratories Inc

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

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 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 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 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

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

Paroex Oral Rinse (Sunstar) – Manufacturing Contamination (2020)

cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

Class IIModerate

FDADec 28, 2020Nationwide• Sunstar Americas, Inc.

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: Professional At Home Artificial Intrauterine Insemination...

Device was distributed without a proper marketing authorization.

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: Pro Series Fertility Device (SKU 644042788139)

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: TenderNeeds Fertility PRO IUI Human Artificial Home Insem...

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 IntraCervical Insemination (ICI) Kit (3), SKU 3829...

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: At Home Artificial Intrauterine Insemination Kit (SKU 636...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: At Home Semi-Flex/Rigid Insemination Device (SKU 64404278...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

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