Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Pack

FDA device recall Z-1968-2011 · posted 2011-04-13 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

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

Action taken

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

Status

Terminated

Product code

KMJ

Quantity affected

4,236 modules

Distribution

Nationwide Distribution

Date initiated

2011-02-28

Date posted

2011-04-13

Date terminated

2012-04-19

Location

Park, IL