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 g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack
- Company
- Cardinal Health
- Recall Initiated
- October 3, 2005
- Posted
- November 18, 2005
- Terminated
- December 21, 2006
- Recall Number
- Z-0163-06
- 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. 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
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.