Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tourniquet, alcohol prep pads, a

FDA device recall Z-3049-2011 · posted 2011-08-22 · Terminated

Recall details

Recalling firm

Churchill Medical Systems, Inc.

Reason for recall

Outer Kit labeled expiration date longer than the expiration of the shortest expired product

Action taken

Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com

Root cause

Employee error

Status

Terminated

Product code

LRS

Quantity affected

130,750 units

Distribution

Nationwide Distribution

Date initiated

2011-07-15

Date posted

2011-08-22

Date terminated

2013-03-27

Location

Dover, NH