Apogee Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 13
At a glance
Market reach
- United States
- FDA recalls
What Apogee Medical, Inc. makes
Apogee Medical, Inc. manufactures urological catheters and closed system intermittent catheterization kits designed for bladder drainage and urinary management.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Urological Catheter Ref K011552
Regimes: 510(k) Registry: 510(k)Closed System Intermittent Catheterization Kit Ref K032710
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 13 recalls initiated by Apogee Medical, Inc., the earliest on 2008-07-17 and the most recent on 2011-03-24. By recorded status: 13 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 24 Mar 2011 Z-2133-2011 Unclassified (pre-2012) Terminated Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.
Full distribution text
- 18 Jan 2011 Z-1034-2011 Unclassified (pre-2012) Terminated This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
Full distribution text
- 18 Jan 2011 Z-1035-2011 Unclassified (pre-2012) Terminated This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
Full distribution text
- 18 Jan 2011 Z-1036-2011 Unclassified (pre-2012) Terminated This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
Full distribution text
- 18 Jan 2011 Z-1037-2011 Unclassified (pre-2012) Terminated This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
Full distribution text
- 18 Jan 2011 Z-1038-2011 Unclassified (pre-2012) Terminated This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
Full distribution text
- 18 Jan 2011 Z-1039-2011 Unclassified (pre-2012) Terminated This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
Full distribution text
- 18 Jan 2011 Z-1040-2011 Unclassified (pre-2012) Terminated This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
Full distribution text
- 24 Mar 2011 Z-2133-2011 Unclassified (pre-2012) Terminated Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.
2008
- 17 Jul 2008 Z-2390-2008 Unclassified (pre-2012) Terminated Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
- 17 Jul 2008 Z-2391-2008 Unclassified (pre-2012) Terminated Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
Show all 13 recalls
2008
- 17 Jul 2008 Z-2392-2008 Unclassified (pre-2012) Terminated Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
- 17 Jul 2008 Z-2393-2008 Unclassified (pre-2012) Terminated Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
- 17 Jul 2008 Z-2394-2008 Unclassified (pre-2012) Terminated Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
Frequently asked questions
How many devices does Apogee Medical, Inc. have in the registry?
The registry currently lists 2 devices for Apogee Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apogee Medical, Inc.'s devices?
Among its 2 most recently registered devices, Apogee Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Apogee Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Apogee Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Apogee Medical, Inc.?
FDA recall records list 13 recalls initiated by Apogee Medical, Inc., the most recent initiated on 24 Mar 2011. 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 Apogee Medical, Inc. in the registry?
The most recently registered devices listed for Apogee Medical, Inc. include UROLOGICAL CATHETER and CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT.