—#42412

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, McGaw Park, Illinois 60085

Distribution

Distribution pattern: South Carolina, New York, Nebraska, Florida and internationally to Canada

Timeline

Recall initiated: 2005-10-03
Posted by FDA: 2005-11-18
Terminated: 2006-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42412. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.