Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: FloridaInfustion Services, Inc., Pa

FDA device recall Z-1333-2011 · posted 2011-02-16 · Terminated

Recall details

Recalling firm

Churchill Medical Systems, Inc.

Reason for recall

Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

Action taken

The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.

Root cause

Vendor change control

Status

Terminated

Product code

FPA

Quantity affected

1380 units

Distribution

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Date initiated

2010-11-16

Date posted

2011-02-16

Date terminated

2012-05-01

Location

Dover, NH

Related 510(k) clearances