||August 09, 2013
||C-QUR Mesh (All Sizes, shapes).
Intended for use in soft tissue deficiencies.
||Product lines with lot number 10405513 and higher
|Atrium Medical Corporation
5 Wentworth Dr
Hudson, New Hampshire 03051-4929
|For Additional Information Contact
|Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
||Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification.
Additional language to the instructions for use (IFU) to include:
Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable.
Questions please contact Atrium Medical Customer Service at 1- 800-
528-7486 Monday through Friday 9:00 am to 5:00 pm EDT.
|Quantity in Commerce
||USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.