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Showing 7661–7680 of 8389 results

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BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy: RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL...

Products labeled as sterile were distributed, but may not have been sterilized.

FDAMar 22, 2021Nationwide• BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy

BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy: BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLA...

Products labeled as sterile were distributed, but may not have been sterilized.

FDAMar 22, 2021Nationwide• BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy

BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL),...

Products labeled as sterile were distributed, but may not have been sterilized.

FDAMar 22, 2021Nationwide• BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy

Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom: Chromosome X Alpha-Satellite in FITC Spectrum - Product U...

Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

FDAMar 19, 2021Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: LINK Endo-Model Modular Knee Prosthesis System Femoral Se...

The firm discovered through customer complaints that device segments may not meet specifications.

FDAMar 18, 2021AL, GA, IL +5 more• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Coltene Whaledent Inc: Dental pins - TMS LINK PLUS Self-Threading Pins - Product...

The incorrect dental pins were packaged and subsequently distributed.

FDAMar 18, 2021Nationwide• Coltene Whaledent Inc

Luminex Corporation: VERIGENE Processor SP - Product Usage: intended for proce...

Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

FDAMar 18, 2021Nationwide• Luminex Corporation

CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Enterprise Viewer

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

FDAMar 17, 2021AK, AZ, CA +15 more• CHANGE HEALTHCARE CANADA COMPANY

ICU Medical, Inc.: REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Cl...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Prod...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

Cardinal Health Inc.: FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Nu...

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

FDAMar 16, 2021Nationwide• Cardinal Health Inc.

ICU Medical, Inc.: REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Prod...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF K7040-001 Spinning Spiros Closed Male Luer - Product ...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF 20120-01 Spiros" Closed Male Luer - Product Usage:...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

Cardinal Health Inc.: BD UF PEN 32GX4MM 100 NANO Item Number: 4292272

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

FDAMar 16, 2021Nationwide• Cardinal Health Inc.

ICU Medical, Inc.: REF 034-H2629 Appx 1.0 ml, Adaptador universal para siste...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

Cardinal Health Inc.: DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

FDAMar 16, 2021Nationwide• Cardinal Health Inc.

Cardinal Health Inc.: VAPORIZER VICKS 1.5GAL Item Number: 2354942

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

FDAMar 16, 2021Nationwide• Cardinal Health Inc.

Cardinal Health Inc.: ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

FDAMar 16, 2021Nationwide• Cardinal Health Inc.

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