MEDICAL DEVICE RECALL BD Insyte Autoguard Catheter

BD- Canada
2100 Derry Road West, Suite 100
Mississauga, ON L5N0B3
tel: 866.979.9408
fax:800.565.0897
www.bd.com
October 2014
MEDICAL DEVICE RECALL
BD InsyteTM AutoguardTM Catheter
Product Name
Cat.
Number
Unit
Lot Number
Exp. Date
BD InsyteTM AutoguardTM
Catheter 20 G x 1.16 in.
381434
each
4107722
April 2017
May 2017
each
4139786
4161662
4164960
4167812
4174713
BD InsyteTM AutoguardTM
Catheter 20 G x 1.00 in.
381433
June 2017
Dear Customer:
BD is conducting a recall of the BD InsyteTM AutoguardTM due to damage at the catheter. Having a
damaged catheter may lead to catheter leakage and the subsequent need for insertion of another IV
catheter. Due to these potential risks, BD has made the decision to voluntarily remove these lots from
the market as a precautionary measure. Appropriate corrective actions have been instituted to address
this condition. No adverse events have been reported for this issue.
This recall only affects the catalogue and lot numbers listed in the table above. At this time, this recall
does not impact any other products or lots.
YOU NEED TO TAKE THE FOLLOWING ACTIONS:
1. Immediately review your inventory for the above-mentioned catalogue and lot numbers, and
quarantine product subject to the recall.
 Please refer to the graphics on the following page for easy identification of the product
and of the affected lot number. The lot number is printed on the device, the shelf pack,
and the case carton.
2. Immediately destroy any affected inventory. Document destroyed product as per step 3 below.
Credit will be issued by your distributor as appropriate, after completion of step 3.
3.
As soon as possible, complete the attached Customer Recall Destruction & Credit Request
Form and return to your distributor using the contact information on the Form.
NOTE: Please complete and return the form even if you do not have affected product on hand.
Your distributor will issue credit to you for product destroyed, once they receive this document.
If you have any technical or clinical questions, please contact Paula Clayton at (905) 288-6237.
Additionally, BD-Canada Customer Service is available at (866) 979-9408.
BD-Canada Recall No. MSS-14-473
Page 1 of 4
BD InsyteTM AutoguardTM Catheter Label Sample
Label Enclosure
Unit Label
Catalogue Number
Location
Shelf Carton Label
Lot Number
Location
Catalogue
Number
Location
Lot
Number
Location
Shipping Case Label
Catalogue
Number
Location
Lot
Number
Location
BD-Canada Recall No. MSS-14-473
Page 3 of 4
BD InsyteTM AutoguardTM Catheter Recall
CUSTOMER RECALL DESTRUCTION & CREDIT REQUEST FORM
Please Return to your Distributor:
(Do not return to BD)
Facility Name:
_______________________________________________________
Address:
_______________________________________________________
City:
_____________________________________________________
Province:
__________________
(please print or type)
Postal Code:
_________________
I have received and understood the Recall Letter dated October 2014, for the above BD
product. I confirm that I have taken action as appropriate.
(Credit will be issued by your distributor for destroyed product)
Lot #
381434
4107722
Yes
4139786
Yes /
No
4161662
Yes /
No
4164960
Yes /
No
4167812
Yes /
No
4174713
Yes /
No
381433
Number of Affected
Eaches on Hand
All Affected Eaches
on Hand have been
Destroyed
Cat. /
Reorder #
No Affected Product on Hand (
Signed:
/
Number of Eaches to
Credit
No
)
Date:
Name: ____________________________________________________________
(please print or type)
Title: _____________________________________________________________
Department: ________________________________________________________
Telephone: __________________________ Fax: ________________________
DISTRIBUTOR OFFICE USE ONLY:
CONFIRMED
INITIAL
BD-Canada Recall No. MSS-14-473
DATE
Page 4 of 4

Download Report