C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.

FDA device recall Z-1938-2013 · posted 2013-08-09 · Terminated

Recall details

Recalling firm

Atrium Medical Corporation

Reason for recall

Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

FTL

Quantity affected

95,286 units

Distribution

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 H

Date initiated

2013-07-19

Date posted

2013-08-09

Date terminated

2016-03-18

Location

Hudson, NH

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