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Showing 22841–22860 of 29086 results

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GMK Intramedullary Extension Rod (Medacta) – Rod Breakage Risk (2014)

Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

Class IIModerate

FDASep 22, 2014OH• Medacta Usa

Digital Mobile X-ray System (Virtual Imaging) – Erratic Motion (2014)

There is a potential for unintended and erratic motion.

Class IIModerate

FDASep 22, 2014Nationwide• Virtual Imaging, Inc.

M&M's (Mars) - Undeclared Peanuts (2014)

Undeclared Nuts

Mars Chocolate North America is recalling M & Ms due to undeclared peanuts.

Class IIModerate

FDASep 19, 2014AZ, AR, CA +34 more• Mars Chocolate North America

PC Organics Wheat Crackers - Undeclared Sesame (2014)

Undeclared Allergen

Product contains undeclared sesame seeds

Class IIModerate

FDASep 19, 2014Nationwide• Venus Wafers Inc.

Nature's Place Trail Mix - Undeclared Cashews (2014)

Undeclared Allergen

The various trail mixes may contain undeclared cashew kernels.

Class IIModerate

FDASep 19, 2014CT, FL, GA +4 more• United Natural Trading

Clinitek Status Power Supply (Siemens) – Electric Shock Risk (2014)

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Carescape Patient Data Module (GE Healthcare) – Data Calculation Issue (2014)

GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an

Class IIModerate

FDASep 19, 2014Nationwide• GE Healthcare, LLC

MaxLock Extreme Mod-Foot Reamer (Orthohelix) – Incorrect Sizing (2014)

Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

Class IIModerate

FDASep 19, 2014IN, MI, MO +10 more• Orthohelix Surgical Designs Inc

Clinitek Status Connect System (Siemens) – Electric Shock Risk (2014)

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Clinitek Status Power Supply (Siemens) – Electric Shock Risk (2014)

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc

Straumann Bone Level Implant (Straumann) – Incorrect Assembly (2014)

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

Class IIModerate

FDASep 19, 2014FL, IN, MA• Straumann USA, LLC

IMMULITE Cortisol System (Siemens) – Control Bias (2014)

Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.

Class IIModerate

FDASep 19, 2014Nationwide• Siemens Healthcare Diagnostics

Central Venous Catheterization Kit (Arrow) – Labeling Error (2014)

Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.

Class IIModerate

FDASep 18, 2014CA, IN, KY +7 more• Arrow International Inc

Mammomat Inspiration System (Siemens) – Biopsy Device Failure (2014)

The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i

Class IIModerate

FDASep 18, 2014IN, MA, NY +1 more• Siemens Medical Solutions USA, Inc

V.A.C. GranuFoam Silver Dressing (KCI) – Expiry Date Error (2014)

A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.

Class IIModerate

FDASep 18, 2014Nationwide• KCI USA, Inc.

EndoWrist Stapler (Intuitive Surgical) – Removal Difficulty (2014)

Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

Class IIModerate

FDASep 18, 2014Nationwide• Intuitive Surgical, Inc.

Calcitonin ELISA Kit (Biomerica) – False High Values (2014)

A potential issue with false high values.

Class IIModerate

FDASep 18, 2014CA, FL, NH +1 more• Biomerica

Cardiopulmonary Bypass Connector (Dokitz) – Detachment Risk (2014)

The single leg of the PAY connector has been observed to become detached.

Class IIModerate

FDASep 18, 2014IL, MD, MO +3 more• Dokitz NovoSci

Xarelto (Janssen) – Microbial Contamination (2014)

Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

Class IIModerate

FDASep 17, 2014Nationwide• Janssen Ortho L.L.C.

Cranberry Macaroon Granola (NatureBox) – Incorrect Label (2014)

Firm discovered a pouch that had an incorrect back label. The front of the pouch was correctly labeled Cranberry Macaroon Granola but the back of the pouch was incorrectly labeled with the label for Cherry Berry Granola.

Class IIModerate

FDASep 17, 2014Nationwide• NatureBox, Inc.

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