Davol Inc., Sub. C. R. Bard, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 25
- FDA recalls
- 32
At a glance
Market reach
- United States
- FDA recalls
What Davol Inc., Sub. C. R. Bard, Inc. makes
Davol Inc. manufactures surgical irrigation systems, including laparoscopic and arthroscopic pulsed irrigators, as well as reusable electrosurgical attachments like J-hook, L-hook, and spatula tips for tissue manipulation. The company also produces hernia repair meshes, such as pre-shaped and composite meshes for ventral and inguinal applications, alongside fluid monitoring systems for hysteroscopy and arthroscopy procedures. Additional offerings include hysteroscopic distention systems, reusable hysteroscopy drapes and tubing sets, and a hysteroscopic pump for controlled fluid management.
The portfolio includes devices regulated as Class II and Class III under FDA authorities, with submissions recorded in the 510(k) and PMA registries. These products are listed under U.S. jurisdiction, reflecting compliance with U.S. medical device regulations.
Catalogue
Search and filter all 25 devicesFDA recalls
2011
- 4 Oct 2011 Z-0144-2012 Unclassified (pre-2012) Terminated Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle.
- 25 Apr 2011 Z-2239-2011 Unclassified (pre-2012) Terminated Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6"
- 11 Apr 2011 Z-2124-2011 Unclassified (pre-2012) Terminated Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm /2.5" packaged in a pre-printed
carton identified for a Bard Ventralex Small Circle
4.3cm /1.7"
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- 7 Jan 2011 Z-1379-2011 Unclassified (pre-2012) Terminated Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.
- 7 Jan 2011 Z-1380-2011 Unclassified (pre-2012) Terminated Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.
- 7 Jan 2011 Z-1381-2011 Unclassified (pre-2012) Terminated Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.
- 7 Jan 2011 Z-1382-2011 Unclassified (pre-2012) Terminated Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.
2010
- 15 Oct 2010 Z-0422-2011 Unclassified (pre-2012) Terminated Mislabeled: Hernia Patch may be a different size than on the product label
- 15 Oct 2010 Z-0423-2011 Unclassified (pre-2012) Terminated Mislabeled: Hernia Patch may be a different size than on the product label
- 15 Oct 2010 Z-0424-2011 Unclassified (pre-2012) Terminated Mislabeled: Hernia Patch may be a different size than on the product label
Show the 25 most recent of 32 recalls
2010
- 15 Oct 2010 Z-0446-2011 Unclassified (pre-2012) Terminated Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).
- 8 Apr 2010 Z-1536-2010 Unclassified (pre-2012) Terminated Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0")
2009
- 30 Jul 2009 Z-1948-2009 Unclassified (pre-2012) Terminated Product sterility may be compromised due to lack of package integrity.
2008
- 8 Dec 2008 Z-0935-2009 Unclassified (pre-2012) Terminated Mislabeled: Product labeled as Left large, may contain a Right Large
2007
- 16 Jul 2007 Z-1266-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 16 Jul 2007 Z-1267-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 16 Jul 2007 Z-1268-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 16 Jul 2007 Z-1269-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 16 Jul 2007 Z-1270-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 16 Jul 2007 Z-1271-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 16 Jul 2007 Z-1272-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 16 Jul 2007 Z-1273-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
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- 10 Jan 2007 Z-0359-2007 Unclassified (pre-2012) Completed PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- 10 Jan 2007 Z-0360-2007 Unclassified (pre-2012) Completed PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- 16 Jul 2007 Z-1266-2007 Unclassified (pre-2012) Terminated Malformed constructs (straight shots) may form causing injury to user/patient
2006
- 27 Dec 2006 Z-0374-2007 Unclassified (pre-2012) Terminated Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
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- 27 Dec 2006 Z-0374-2007 Unclassified (pre-2012) Terminated Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
Frequently asked questions
How many devices does Davol Inc., Sub. C. R. Bard, Inc. have in the registry?
The registry currently lists 25 devices for Davol Inc., Sub. C. R. Bard, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Davol Inc., Sub. C. R. Bard, Inc.'s devices?
Among its 25 most recently registered devices, Davol Inc., Sub. C. R. Bard, Inc. has devices listed in FDA 510(k) (24 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Davol Inc., Sub. C. R. Bard, Inc.'s devices fall under?
Among its 25 most recently registered devices, the classes recorded for Davol Inc., Sub. C. R. Bard, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Davol Inc., Sub. C. R. Bard, Inc.?
FDA recall records list 32 recalls initiated by Davol Inc., Sub. C. R. Bard, Inc., the most recent initiated on 2011-10-04. 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 Davol Inc., Sub. C. R. Bard, Inc. in the registry?
The most recently registered devices listed for Davol Inc., Sub. C. R. Bard, Inc. include BARD HYSTERO-FLO II PUMP, VENTRALIGHT ST MESH, SALUTE FIXATION SYSTEM and HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010.