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U.S. Department of Health and Human Services

Class 2 Device Recall Davol

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  Class 2 Device Recall Davol see related information
Date Initiated by Firm July 16, 2007
Date Posted September 27, 2007
Recall Status1 Terminated 3 on August 16, 2018
Recall Number Z-1269-2007
Recall Event ID 38634
510(K)Number K050610  
Product Classification Laproscopic 38cm Sterile Implant Cartridge - Product Code GDW
Product Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;5/Box, Item Number: 0113058
Code Information All lots
Recalling Firm/
Manufacturer		 Davol, Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Cranston RI 02920
For Additional Information Contact Robin Drago
401-463-7000
Manufacturer Reason
for Recall		 Malformed constructs (straight shots) may form causing injury to user/patient
FDA Determined
Cause 2		 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 33,994 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = DAVOL INC., SUB. C.R. BARD, INC.
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