C
COVIDIEN
URGENT MEDICAL DEVICE RECALL
June 2, 2011
Subject: RECALL: Various production lots ofCovidien Sutures listed below:
Surgilon™ non-absorbable braided nylon sutures
Ticron™ non-absorbable polyester sutures
Sofsilk™ non-absorbable silk sutures
REF#:
Product Lot #:
Expiration Date:
VARIOUS (SEE ATTACHED LIST)
VARIOUS (SEE ATTACHED LIST)
VARIOUS
Dear Customer,
This letter is to inform you that Covidien is conducting a voluntary medical device recall of
certain Surgilon™ non-absorbable braided nylon sutures, Ticron™ non-absorbable
polyester sutures and Sofsilk™ non-absorbable silk sutures. This recall only affects the
material codes and lot numbers provided on the Product Inventory Recall Form (attached). This
voluntary recall is being conducted due to the potential for the sterile barrier to be compromised.
We have not received any reports indicating adverse health effects related to these products have
occurred however, the use of potentially non-sterile product may result in infection.
Please assess your inventory and follow the steps below. You will receive credit for the returned
units.
1. Inunediately identifY and quarantine all affected inventory.
NOTE: Units from the affected lots may have been incorporated Into Covidien Suture US
P llcks. Ifyou have purchascd US Packs, please evaluate wh ether these kits contaln unUs
from tbe affected lots.
2. Distributors who have received and have further distributed the affccted product must forward
this notification to their customers who received the affected product.
3. Contact Covidien Customer Service at SDFeedback(al,Covidien.col11 or (800) 722-8772, option I,
to obtain a Return Material Authorization (RMA) prior to returning the affected units. Covidien
will mange for shipment pickup and will cover a11 freight costs associated with the return.
Page 1 of4
COVIDlEN
60MJODLETOWN AVE
NORTH HAvrn, er 06473
(800) 722 • 8772{T}
(203)822 • 6009(F}
COVI D IEN
4. Comp!ete the attached product reca1! fonn in its entirety. Fax the completed fonn to (203) 8226009 and include a copy with products being returned. Ifyou do not have any ofthe affected
lots in your inventory, simply return tbe recall fonn via fax or email to
[email protected], indicating you have zero units.
5. Ship affected product(s) with the RMA # provided by Customer Service to:
Covidien
Attn: Field Returns Department
195 McDennott Road
North Haven, CT 06473 USA
Please note, this voluntary recall is limited to the material codes and lot nunlbers provided on the
attached list and does NOT affect any other lots or Covidien devices. This voluntary recall is
being conducted with tbe knowledge ofthe FDA.
We ask that you reply to Covidien WHETHER OR NOT you have affected product at your site.
Y our response is vital to our monitoring of the effectiveness of this recal!.
We apologize for any inconvenience this may have caused and thank you for your business and
continued support. If you have any questions or concerns, please do not hesitate to contact your
Covidien Representative or Covidien Quality Assurance at (203) 492-5232.
Sincerely,
Garrett Raymond
Vice President, Global Quality Assurallce & Rcgulatory Affairs
Ellclosures: Recalled Suture Product Inventory Fonn
Page 2 of4
COVIDIEN
60MIODlETOWN AVE
NORTIlHAVEN, CT06473
(800) 722 - 8772{T}
(203)822 - 6009(F)
~:I COVIDIEN
[Please illsert date thefarm w as sentl
URGENT MEDICAL DEVICE FSCA
PRODUCT RECALL
Sutures: Surgilon™, Ticron™ and Sofsilk™
VERIFICATION FORM
Covidien Contact Details
Customer Contact Details
Hospital Name:
Ta: [please insert name Cavidien cammercial office]
Address:
Address: [please insert Covidien address]
Telephone nO:
Telephone nO: [please insert Covidien telephone number]
Fax nO:
Fax nO: [please insert Covidien fax numberJ
E-mail:
E-mail : [please inser t contact e-mail address]
Please li st the quantity of affected product at your facility, if you have no stock, please indicate '0'.
Part Number
Lot number
8886193662
D1B0584X
8886 193662
D1 C0245X
8886193662
D1 C0292X
Qty
Please indicate your Purchase Order number in order to re ceive replacement products_ _ __ __
Pl ease fa x thi s form t o the fa x number referenced at the t op of this form .
Customer Service will contact you directly to organise return of affected products or to issue credit.
Name:
(please print)
Signature:
Date: