Recall Z-0141-2012 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 for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Split Dressing - 2"x 2", Yellow, component
| Date | Oct 31, 2011 (initiated Sep 3, 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 | Component design/selection |
| Action | Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 2, 2011 to all affected consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which 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 to affix to the front side of each affected Presource kit in their inventory. The labels have an ID code which coincides with the code on the comp |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.