Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) Cat. PO23AAMCC - Arthroscopy Kit b) Cat. PO23TKMCC - Total Knee Kit c) Cat. SOP11OPFGB - Ortho Pack d) Cat. SCV48CVJHD - Strl Open Heart Part A & B Pk
- Company
- Cardinal Health
- Recall Initiated
- October 3, 2005
- Posted
- November 18, 2005
- Terminated
- December 21, 2006
- Recall Number
- Z-0164-06
- Firm Location
- McGaw Park, IL
Reason for Recall
The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.
Distribution
South Carolina, New York, Nebraska, Florida and internationally to Canada
Lot / Code Info
Cat. PO23AAMCC, order numbers 641370 and 655171; Cat. PO23TKMCC, order numbers 637245 and 639306; Cat. SOP11OPFGB, order numbers 640349, 641634, 644009, 651563 and 653696; Cat. SCV48CVJHD, order numbers 722851 and 728463.
Root Cause
Other
Action Taken
Cardinal Health notified the accounts who ordered the affected packs via letter dated 10/3/05, informing them that the packs that were labeled latex-free actually contained an elastic bandage that contained latex rubber. The letters were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to telephone Cardinal Customer Service at 1-800-964-5227 for return instructions for the affected packs return to Cardinal Health for replacement.