Z-1272-2007

Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043

Name: Z-1272-2007 Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2007-07-16
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2007-07-16 / Terminated / root cause: design

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043 on 2007-07-16. The reason FDA records is "Malformed constructs (straight shots) may form causing injury to user/patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1272-2007
Status: Terminated
Initiated: 2007-07-16
Posted: 2007-09-27
Terminated: 2018-08-16
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043
Product code: GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Reason for recall: Malformed constructs (straight shots) may form causing injury to user/patient
Root cause tag: design
FDA root cause: Device Design
Action: Davol issued recall letter notification on 7/16/07 via Federal Express. Sales of the disposable cartridges ceased July 31, 2007. Cartridges will not be requested to be returned to Davol. Customer requests to return cartridges will be managed on an account-by-account basis. A reminder Second Letter issued July 23,2007 as a follow-up to the letter of July 16, 2007. The second stage will be a series of three letters to customers following the cessation of disposable cartridge sales and to recall the re-usable handles. A Stock Status form will be provided to customers to inventory the product which they are returning. The Stock Status form will be used to document the handles being returned. In the event that the customer cannot locate one or more handles. All handles will be returned to Cranston and will be dispositioned. Account verification for the number of handles returned from the account will be performed. No verification testing will be performed on returned handles unless a formal complaint has been registered for a handle.
Quantity in commerce: 9,333 units
Distribution: Worldwide-USA and Canada, Austria, Switzerland, Spain, Sweden, United Kingdom, Italy,Portugal, Greece,Holland, South Africa, Israel, Japan, Belgium, Denmark, Finland, France, and Germany
Product codes and lots: All lots

Product code GWD

K050610Class IISalute Fixation SystemDavol Inc., Sub. C. R. Bard, Inc. / cleared 2005-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)