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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health Presource PBDS Convenience Kits

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  Class 2 Device Recall Cardinal Health Presource PBDS Convenience Kits see related information
Date Initiated by Firm October 03, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on December 21, 2006
Recall Number Z-0164-06
Recall Event ID 33767
Product Classification General Surgery Tray - Product Code LRO
Product 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
Code Information 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.
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
McGaw Park IL 60085
For Additional Information Contact Michelle Donatich R.N.
800-964-5227
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.
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
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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