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Class 2 Device Recall Cardinal Health Custom Sterlie Convenience Kits |
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Date Initiated by Firm |
October 03, 2005 |
Date Posted |
November 18, 2005 |
Recall Status1 |
Terminated 3 on December 21, 2006 |
Recall Number |
Z-0163-06 |
Recall Event ID |
33767 |
Product Classification |
General Surgery Tray - Product Code LRO
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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
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Code Information |
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 |
Recalling Firm/ Manufacturer |
Cardinal Health 1430 Waukegan Rd McGaw Park IL 60085
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For Additional Information Contact |
Michelle Donatich R.N. 800-964-5227
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Manufacturer 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.
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FDA Determined Cause 2 |
Other |
Action |
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. |
Distribution |
South Carolina, New York, Nebraska, Florida and internationally to Canada |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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