Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LI

FDA device recall Z-1140-2010 · posted 2010-03-15 · Terminated

Recall details

Recalling firm

Centurion Medical Products

Reason for recall

A supplier notified this firm of a recall of their Huber needles because the needles that are labeled as non-coring could core 60-72% of the time. Centurion is doing a sub recall of their kits that contain the referenced needles.

Action taken

An "URGENT MEDICAL DEVICE WITHDRAWAL" notice dated January 26, 2010, was sent to customers via certified mail. The notice described the product, problem and action to be taken by the customers. The customers were instructed: DO NOT USE THESE AFFECTED PRODUCTS. PLEASE RETURN ALL AFFECTED PRODUCTS IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED. The customers were also instructed to report any adverse reactions experienced with the use of the product and/or quality problems to MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078 by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch. The customers were also instructed to check the lot numbers of products in inventory to determine if they have products affected by this withdrawal and complete and return the enclosed Customer Response Form by fax or email. Direct all inquiries to: EXEL International Customer Service 727-827-1922 ext. 0 Monday through Friday 9am-5pm EST or E-mail info@exelint.com

Root cause

Other

Status

Terminated

Product code

FMI

Quantity affected

880 kits

Distribution

USA only

Date initiated

2010-02-01

Date posted

2010-03-15

Date terminated

2010-11-08

Location

Howell, MI