—#106597

Product

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: a) Cool Peri-Pad Self-Adhesive Absorbent Pad with Built-In Cold Pack, component C-CP23, vendor part number CP23; b) Giraffe Disposable Skin Temperature Probe, vendor part number 6600-0873-700;

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: all recent lots of the following kit catalog numbers ICU955327G, ICU955327H, and MAT330041C.

Why it was recalled

Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product.

Root cause (FDA determination)

PMA

Action the firm took

Cardinal Health issued an URGENT: PRODUCT RECALL letter dated December 12, 2011 to the affected hospital consignees via UPS next day air. The letter informed them that their Presource kits listed in the attached spreadsheet contain various components also listed on the attachment that are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels, instructing the user not to use the affected component upon opening the kit, to be affixed to the front side of each affected Presource kit and shipping carton in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit, the consignees were instructed to contact Presource Sales Operations at 800-766-0706.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Nationwide Distribution -- California, Georgia, Illinois, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.

Timeline

Recall initiated: 2011-12-12
Posted by FDA: 2012-01-26
Terminated: 2016-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.