Smiths Medical MD, Inc.
United StatesFDA applicant, unverified
- Devices
- 20
- FDA recalls
- 70
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Search and filter all 20 devicesFDA recalls
2008
- 18 Dec 2008 Z-1018-2009 Unclassified (pre-2012) Terminated 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.
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- 18 Dec 2008 Z-1019-2009 Unclassified (pre-2012) Terminated 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.
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- 9 Dec 2008 Z-0987-2009 Unclassified (pre-2012) Terminated 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
- 20 Nov 2008 Z-0988-2009 Unclassified (pre-2012) Terminated 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
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- 20 Nov 2008 Z-0989-2009 Unclassified (pre-2012) Terminated 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
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- 10 Mar 2008 Z-1622-2008 Unclassified (pre-2012) Terminated 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.
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- 10 Mar 2008 Z-1623-2008 Unclassified (pre-2012) Terminated 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.
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- 7 Mar 2008 Z-1621-2008 Unclassified (pre-2012) Terminated 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.
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- 27 Feb 2008 Z-1604-2008 Unclassified (pre-2012) Terminated 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.
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- 27 Feb 2008 Z-1605-2008 Unclassified (pre-2012) Terminated 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.
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- 18 Dec 2008 Z-1018-2009 Unclassified (pre-2012) Terminated 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.
Show the 25 most recent of 70 recalls
2008
- 22 Feb 2008 Z-1590-2008 Unclassified (pre-2012) Terminated 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
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- 22 Feb 2008 Z-1591-2008 Unclassified (pre-2012) Terminated 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 gl
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- 22 Feb 2008 Z-1641-2008 Unclassified (pre-2012) Terminated 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
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- 22 Feb 2008 Z-1590-2008 Unclassified (pre-2012) Terminated 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
2007
- 14 Dec 2007 Z-0876-2008 Unclassified (pre-2012) Terminated Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
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- 14 Dec 2007 Z-0877-2008 Unclassified (pre-2012) Terminated Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
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- 14 Dec 2007 Z-0878-2008 Unclassified (pre-2012) Terminated Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
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- 14 Dec 2007 Z-0879-2008 Unclassified (pre-2012) Terminated Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
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- 14 Aug 2007 Z-0134-2008 Unclassified (pre-2012) Terminated 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.
- 18 Jun 2007 Z-1213-2007 Unclassified (pre-2012) Terminated 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.
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- 18 Jun 2007 Z-1214-2007 Unclassified (pre-2012) Terminated 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.
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- 18 Jun 2007 Z-1215-2007 Unclassified (pre-2012) Terminated 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.
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- 3 Feb 2007 Z-0768-2007 Unclassified (pre-2012) Terminated 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.
- 19 Jan 2007 Z-0718-2007 Unclassified (pre-2012) Terminated 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.
- 14 Dec 2007 Z-0876-2008 Unclassified (pre-2012) Terminated Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
2006
- 27 Sep 2006 Z-0064-2007 Unclassified (pre-2012) Terminated 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.
- 27 Sep 2006 Z-0065-2007 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Smiths Medical MD, Inc. have in the registry?
The registry currently lists 20 devices for Smiths Medical MD, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smiths Medical MD, Inc.'s devices?
Among its 20 most recently registered devices, Smiths Medical MD, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Smiths Medical MD, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Smiths Medical MD, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Smiths Medical MD, Inc.?
FDA recall records list 70 recalls initiated by Smiths Medical MD, Inc., the most recent initiated on 18 Dec 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Smiths Medical MD, Inc. in the registry?
The most recently registered devices listed for Smiths Medical MD, Inc. include DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817, SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS, POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS and PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER.