Smiths Medical MD, Inc. Recalls

All product recalls associated with Smiths Medical MD, Inc..

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Recall Summary

Total Recalls

23

Past Year

0

Class I (Serious)

0

Most Recent

Dec 2008

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 23 recalls

Smiths Medical MD, Inc.: Smiths Medical Medfusion Model 3500 Syringe Infusion Pump...

Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump inoperable or the Pump may not respond to certain keypad button presses.

FDADec 18, 2008Nationwide• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: CADD Medication Cassette Reservoir 100 ml with Clamp and ...

Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due

FDADec 9, 2008PA• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Ins...

Smiths Medical has become aware of a display irregularity with the Deltec Cozmo Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what w

FDANov 20, 2008AL, AK, AZ +48 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical Int...

Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.

FDAMar 10, 2008AL, AK, AZ +44 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Med...

Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS 3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury to the user.

FDAMar 7, 2008FL, GA, HI +6 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX...

The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.

FDAFeb 27, 2008AL, AZ, AR +43 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only,...

The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.

FDAFeb 27, 2008AL, AZ, AR +43 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only...

Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their Pump, there is a potentia

FDAFeb 22, 2008AZ, CA, FL +16 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump, model 21-1700. A syringe infus...

Smith Medical has received reports of Deltec Cozmo Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood g

FDAFeb 22, 2008AL, AK, AZ +49 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Smiths CADD Yellow Medication Cassette Reservoirs with Cl...

Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

FDADec 14, 2007AL, AK, AZ +48 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Smiths CADD Medication Cassette Reservoirs with Clamp and...

Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

FDADec 14, 2007AL, AK, AZ +48 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Smiths Medical CADD-Sentry Pro Medication Safety Software...

Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.

FDAAug 14, 2007CO, MD, UT• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Smiths CADD Medication Cassette Reservoir, With clamp and...

Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering Flolan.

FDAJun 18, 2007PR• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Smiths CADD Yellow Medication Cassette Reservoir, With cl...

Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan.

FDAJun 18, 2007PR• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Medfusion 3500 Syringe Infusion Pump with PharmGuard Medi...

Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.

FDAFeb 3, 2007Nationwide• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec branded CADD-Prizm PCS II ambulatory infusion pump...

The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.

FDAJan 19, 2007Nationwide• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Locator-Wand Cover that is sold in a shelf carton (unit p...

Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.

FDASep 27, 2006CA, FL, MD +4 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Locator-Wand Cover that is sold in a shelf carton (unit ...

One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.

FDAMar 29, 2006Nationwide• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Large-Volume IV Administration Sets for use with Deltec 3...

Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

FDADec 8, 2005SC, PR• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec branded Administration Sets for use with Deltec 30...

Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate..

FDADec 3, 2004Nationwide• Smiths Medical MD, Inc.

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