Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylon Nonabsorbable Surgical Sutur

FDA device recall Z-1104-2012 · posted 2012-02-24 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

The Presource kits were assembled with Ethicon Sutures in new Tyvek packaging which could no longer be placed in kits that will undergo ethylene oxide sterilization.

Action taken

The firm, Cardinal Health, sent an "URGENT: PRODUCT RECALL" letter dated January 26, 2012 to the affected consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected sutures and to remove and destroy the sutures upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers were also requested to complete and fax back to Cardinal at 847-689-9101 or 614-652-9648 regardless of whether or not you have inventory. For component credit/replacement the consignees were instructed to contact the following: Presource Sales Operations at 800-766-0706; Government Customer Service at 800-444-1166; and Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.

Root cause

Packaging change control

Status

Terminated

Product code

LRO

Quantity affected

18,300 kits

Distribution

Worldwide distribution: USA (Nationwide) including the states of: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Marylan

Date initiated

2012-01-27

Date posted

2012-02-24

Date terminated

2016-08-01

Location

Park, IL