Kensey Nash Corp.
United StatesFDA applicant, unverified
- Devices
- 25
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Kensey Nash Corp. makes
Kensey Nash Corp. manufactures surgical and medical devices including endoscopic graspers, thrombectomy catheters, collagen-based dental membranes, bone void fillers, and surgical meshes. Their portfolio also covers extraction catheters and biomaterial matrices for wound care and tissue integration.
The company’s devices are primarily classified as Class II under FDA regulations, with most authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 25 devicesFDA recalls
FDA recall records list 12 recalls initiated by Kensey Nash Corp., the earliest on 2006-04-06 and the most recent on 2012-02-28. By recorded status: 12 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, packaging and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 28 Feb 2012 Z-1621-2012 Not yet classified Terminated Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
- 28 Feb 2012 Z-1622-2012 Not yet classified Terminated Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
- 28 Feb 2012 Z-1623-2012 Not yet classified Terminated Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
2007
- 21 May 2007 Z-1115-2007 Unclassified (pre-2012) Terminated Defective component (power supply)
- 28 Mar 2007 Z-0833-2007 Unclassified (pre-2012) Terminated Insufficient wire sealing
- 28 Mar 2007 Z-0834-2007 Unclassified (pre-2012) Terminated Insufficient wire sealing
- 28 Mar 2007 Z-0835-2007 Unclassified (pre-2012) Terminated Insufficient wire sealing
- 7 Feb 2007 Z-0597-2007 Unclassified (pre-2012) Terminated Face seal may wear excessively and cause particulate matter.
2006
- 24 May 2006 Z-1219-06 Unclassified (pre-2012) Terminated Volume control knob not able to go up to larger diameters
- 24 May 2006 Z-1220-06 Unclassified (pre-2012) Terminated volume control knob not able to go up to larger diameters
Show all 12 recalls
2006
- 24 May 2006 Z-1221-06 Unclassified (pre-2012) Terminated volume control knob not able to go up to larger diameters
- 6 Apr 2006 Z-1305-06 Unclassified (pre-2012) Terminated Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting
Frequently asked questions
How many devices does Kensey Nash Corp. have in the registry?
The registry currently lists 25 devices for Kensey Nash Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kensey Nash Corp.'s devices?
Among its 25 most recently registered devices, Kensey Nash Corp. has devices listed in FDA 510(k) (25 devices).
What risk classes do Kensey Nash Corp.'s devices fall under?
Among its 25 most recently registered devices, the classes recorded for Kensey Nash Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Kensey Nash Corp.?
FDA recall records list 12 recalls initiated by Kensey Nash Corp., the most recent initiated on 28 Feb 2012. 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 Kensey Nash Corp. in the registry?
The most recently registered devices listed for Kensey Nash Corp. include KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER, TRIACTIV SYSTEM, MESO WOUND MATRIX and QUICKCAT EXTRACTION CATHETER, MODEL 60090-01.