Recall Z-1968-2011 ยท KMJ Lubricant, Patient
Cardinal Health
Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. Designed to assist hospitals in preparing for procedures by group
| Date | Apr 13, 2011 (initiated Feb 28, 2011) |
| Status | Terminated |
| Reason | The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly. |
| Root cause | Employee error |
| Action | Cardinal Health issued an URGENT: PRODUCT RECALL letter dated February 28, 2011 to all affected consignees via UPS next day air, informing them that their Presource kit/modules listed in the attached spreadsheet contain a non-sterile petroleum-based lubricating jelly instead of the labeled water-based sterile lubricating jelly. Cardinal instructed the accounts to quarantine the pack/modules with the indicated work order/lot number on the enclosed spreadsheet and contact the appropriate Customer Service group listed in the letter for return instructions. The accounts were also requested to com |
| Quantity | 4,236 modules |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.