Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)

FDA device recall Z-1267-2007 · posted 2007-09-27 · Terminated

Recall details

Recalling firm

Davol, Inc., Sub. C. R. Bard, Inc.

Reason for recall

Malformed constructs (straight shots) may form causing injury to user/patient

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GDW

Quantity affected

4,242 shafts

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

Date initiated

2007-07-16

Date posted

2007-09-27

Date terminated

2018-08-16

Location

Cranston, RI

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