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Showing 23461–23480 of 29086 results

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Prismaflex M60 set. Product number 106696. Each set is pa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir (ICU Medical, Inc.) – icu has become aware of an issue with... (2014)

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class IIModerate

Jul 18, 2014

OR

• ICU Medical, Inc.

X-MARS Set (Gambro) – Connector Breakage (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prismaflex HF 1000. Product number 107140. Each set is pa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

RENASYS EZ/ RENASYS EZ Plus (Smith & Nephew, Inc.) – renasys ez canisters exhibiting visib... (2014)

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

RENASYS EZ/ RENASYS EZ Plus (Smith & Nephew, Inc.) – renasys ez canisters exhibiting visib... (2014)

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

Prismaflex M150. Product number 109990. Each set is packa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Transpac IT Reservoir (ICU Medical) – Connection Crack Risk (2014)

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class IIModerate

FDAJul 18, 2014OR• ICU Medical, Inc.

Transpac IT Kit (ICU Medical) – Connection Crack Risk (2014)

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class IIModerate

FDAJul 18, 2014OR• ICU Medical, Inc.

Prisma M 60 PRE set (new design). Product number 103658. ... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

PrisMARS Kit (Gambro) – Connector Breakage (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prismaflex M100. Product number 106697. Each set is packa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Tetrahydrozoline Hydrochloride (Spectrum) – CGMP deviation (2014)

CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Class IIModerate

FDAJul 18, 2014CA• Spectrum Laboratory Products

Single Transpac IT Monitoring Kit w/ (ICU Medical, Inc.) – icu has become aware of an issue with... (2014)

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class IIModerate

FDAJul 18, 2014OR• ICU Medical, Inc.

Prismaflex TPE 2000 set, Product Number 1071441. Each set... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M60 POSTDILUTION set. Product number 104183. Each ... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M 100 PRE set. Product number 103657. Each set is ... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M100 PRE pump infusion set. Product number 107791.... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M100 set. Product number 104182. Each set is packa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Arterial Transpac IT Monitoring Kit w/Safeset Reservoir (ICU Medical, Inc.) – icu has become aware of an issue with... (2014)

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class IIModerate

FDAJul 18, 2014OR• ICU Medical, Inc.

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