Recall Z-0872-2012 ยท LRP Tray, Surgical
Cardinal Health
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
| Date | Jan 26, 2012 (initiated Dec 12, 2011) |
| Status | Terminated |
| Reason | 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 | PMA |
| Action | 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 affecte |
| Quantity | 7,213 each |
| Distribution | Nationwide Distribution -- California, Georgia, Illinois, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.