Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended use is a central line dressing k

FDA device recall Z-2389-2011 · posted 2011-06-11 · Terminated

Recall details

Recalling firm

Vygon Corporation

Reason for recall

Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

Action taken

A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LKB

Quantity affected

4,000 units

Distribution

United States (FL, MA, MD, and VA).

Date initiated

2011-04-19

Date posted

2011-06-11

Date terminated

2012-06-18

Location

Montgomeryville, PA