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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 Kitssee related information
Date Initiated by FirmOctober 03, 2005
Date PostedNovember 18, 2005
Recall Status1 Terminated 3 on December 21, 2006
Recall NumberZ-0164-06
Recall Event ID 33767
Product Classification General Surgery Tray - Product Code LRO
ProductCardinal 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.
FEI Number 3001236905
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
McGaw Park IL 60085
For Additional Information ContactMichelle 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
ActionCardinal 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.
DistributionSouth Carolina, New York, Nebraska, Florida and internationally to Canada
Total Product Life CycleTPLC 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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