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Terminated

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 grouping all of the necessary components used for a procedure in one wrapper.

FDA Recall Z-1968-2011 · Posted 2011-04-13

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeKMJ
Date Initiated2011-02-28
Date Terminated2012-04-19
Product Quantity4,236 modules

Reason for Recall

The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly.

Firm 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 complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules being returned. If the product was further distributed, then those customers should also be notified.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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