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Showing 21521–21540 of 22584 results

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ACMI CORPORATION: ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR...

Product sterility may be compromised due to the lack of package seal integrity

FDAApr 30, 2004Nationwide• ACMI CORPORATION

ACMI CORPORATION: ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR ...

Product sterility may be compromised due to the lack of package seal integrity

FDAApr 30, 2004Nationwide• ACMI CORPORATION

Baxa Corporation: Exacta-Mix Valve Set, Primary Valve with Detachable Pump ...

A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

FDAApr 30, 2004Nationwide• Baxa Corporation

Baxter Healthcare Corp. Rt.: Micromix Compounder Implementation Guide; this guide is d...

The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.

FDAApr 30, 2004Nationwide• Baxter Healthcare Corp. Rt.

Arjo, Inc.: Minstrel Patient Lift; a non-AC-powered patient lift; Arj...

The hanger bar may detach from the jib yoke, and the M8 bolt in the foot pedal assembly may come loose, resulting in the patient lift becoming unstable.

FDAApr 30, 2004CO, CT, FL +20 more• Arjo, Inc.

Baxter Healthcare Corp. Rt.: Compounding Brochure titled ''Nutrition Compounding Simpl...

The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.

FDAApr 30, 2004Nationwide• Baxter Healthcare Corp. Rt.

ACMI CORPORATION: ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x...

Product sterility may be compromised due to the lack of package seal integrity

FDAApr 30, 2004Nationwide• ACMI CORPORATION

ACMI CORPORATION: ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 F...

Product sterility may be compromised due to the lack of package seal integrity

FDAApr 30, 2004Nationwide• ACMI CORPORATION

Baxa Corporation: Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled

A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

FDAApr 30, 2004Nationwide• Baxa Corporation

Baxa Corporation: Exacta-Mix Valve Set, Secondary Valve Assembly

A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

FDAApr 30, 2004Nationwide• Baxa Corporation

Biotronik Inc: Deikos A+

Potential for device to not deliver full amount of energy

FDAApr 29, 2004Nationwide• Biotronik Inc

Biotronik Inc: Tachos ATx

Potential for device to not deliver full amount of energy

FDAApr 29, 2004Nationwide• Biotronik Inc

Premier Dental Products Co: Nitrospray Plus (Item #1006060) with a 16 ounce fill capa...

Cryogen can escape from canister through the seal ring

FDAApr 29, 2004Nationwide• Premier Dental Products Co

Biotronik Inc: Tachos DR - Atrial Tx

Potential for device to not deliver full amount of energy

FDAApr 29, 2004Nationwide• Biotronik Inc

Premier Dental Products Co: Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill...

Cryogen can escape from canister through the seal ring

FDAApr 29, 2004Nationwide• Premier Dental Products Co

Biotronik Inc: Tachos DR - Implantable Cardioverter Defibrillator

Potential for device to not deliver full amount of energy

FDAApr 29, 2004Nationwide• Biotronik Inc

American Medical Systems: AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Leng...

The product is mislabeled as to length.

FDAApr 29, 2004CA, IN, TX +1 more• American Medical Systems

Baxter Healthcare Corp. Rt.: Baxter Clearlink Intravenous (IV) Delivery System; the s...

Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.

FDAApr 28, 2004Nationwide• Baxter Healthcare Corp. Rt.

Steris Corportion: STERIS Kindest Kare Perineal Cleanser Incontinence System...

The product failed microbial limits specification upon release and was distributed

FDAApr 28, 2004AZ, FL, IN +3 more• Steris Corportion

Medtronic Gastroenterology Urology: Medtronic Gastro pH in a Box System, Model 43A008, Catalo...

Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.

FDAApr 28, 2004Nationwide• Medtronic Gastroenterology Urology

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