Date Initiated by Firm |
December 02, 2022 |
Date Posted |
February 25, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1179-2023 |
Recall Event ID |
91324 |
510(K)Number |
K954808
|
Product Classification |
Suture, nonabsorbable, synthetic, polypropylene - Product Code GAW
|
Product |
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
|
Code Information |
GTIN:
20884521037868,
20884521036519,
20884523004387,
20884521036540,
20884521037868.
Model Number Lot #
CP535 D2C1521Y
D2E1342Y
D2E1580Y
D2E2678Y
D2E2679Y
D2F0509Y
CP824 D2D0251Y
CP825 D2C3234Y
VP543 D2B1270Y
D2D1493Y
D2E1389Y
|
Recalling Firm/ Manufacturer |
Covidien, LP 60 Middletown Ave North Haven CT 06473-3908
|
For Additional Information Contact |
Medtronic Customer Service 800-962-9888
|
Manufacturer Reason for Recall |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter to US consignees on 01-Dec-2022 via UPS 2-day delivery. OUS countries, notifications are handled via a regionally approved method.
Letter states reason for recall, health risk and actions to take:
Actions: " Identify and quarantine all unused and non-expired affected non-absorbable sutures.
" Please note the affected product may be located within Custom Suture Packs. Please reference Custom Suture Packs to identify affected product.
" Please complete the enclosed Customer Confirmation Form (even if your account no longer has affected product on hand) and email to rs.gmbfcamitg@medtronic.com.>
" Return all unused and non-expired affected product in your inventory to Medtronic as indicated in the Shipping and Return Instructions below.
" Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed.
Shipping and Return Instructions:
" Product purchased directly from Medtronic please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Good Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product.
" Credit or Replacement for the returned affected product will be issued based on the RGA number.
" Return all unused and non-expired affected product(s) in your inventory to:
Medtronic, Attn: Field Returns Dept.
195 McDermott Road, North Haven, CT 06473 USA.
" If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor.
If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888. |
Quantity in Commerce |
8604 units |
Distribution |
US Nationwide Distribution and OUS Foreign distribution to countries of:
Albania
Argentina
Armenia
Australia
Austria
Azerbaijan
Belarus
Belgium
Bosnia And Herzegovina
Brazil
Bulgaria
Cambodia
Cameroon
Canada
Canary Islands
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Egypt
Finland
France
Georgia
Germany
Ghana
Greece
Hong Kong
Hungary
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
JAPAN
Jordan
Kazakhstan
Kenya
Korea, Republic Of
Kosovo
Kuwait
Latvia
Lebanon
Lithuania
Macao
Malaysia
Malta
Mauritius
Mexico
Moldova, Republic Of
Morocco
Myanmar
Namibia
Netherlands
New Zealand
North Macedonia
Norway
Pakistan
Panama
Paraguay
Philippines
Poland
Portugal
Reunion
Romania
Russian Federation
Saudi Arabia
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Thailand
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Viet Nam
Zimbabwe
|
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = GAW and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
|