FDA Device

Cardinal Health Custom Sterile 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. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack

Hazard

The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.

What You Should Do

Remedy

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.

Products

Cardinal Health Custom Sterile 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
Brand
Cardinal Health
UPC
Cat. POOCOTFGB, order numbers 9904815, 9911445, 9911446, 9923559, 9926928, 9929035 and 9932551; Cat.SOP22ARCLC, order number 144191;  Cat. SOP30ARCOB, order number 704460;  Cat. SOP30ARCOC, order numbers 713043 and 717623;  Cat. SOP30ARKGC, order number 716550;  Cat. SOP30ARMCB, order numbers 708643 and 717298;  Cat. SOP30ARNOA, order number 728554;  Cat. SOP30KANRA, order number 708579;  Cat. SOP30LENHC, order numbers 702865 and 714615;  Cat. SOP30SADTE, order number 717371;  Cat. SOP30THDTD, order number 715392;  Cat. SOP30THNOA, order number 728333;  Cat. SOP30THSJA, order number 710742;  Cat. SOP30TKSJA, order number 709389;  Cat. SOP30THVCH, order numbers 709885 and 719564;  Cat. SOP30TKVCE, order numbers 703408 and 716341