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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Sterile Cardiac Cath Pack

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 Class 2 Device Recall Custom Sterile Cardiac Cath Packsee related information
Date Initiated by FirmNovember 15, 2003
Date PostedDecember 24, 2003
Recall Status1 Terminated 3 on October 20, 2005
Recall NumberZ-0266-04
Recall Event ID 27757
Product Classification unknown device name - Product Code HAP
ProductCustom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
Code Information catalog number SAN25CCEAQ, lot numbers 548727, 548723, 544906, 542967, 542966
FEI Number 3001236905
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
McGaw Park IL 60085
For Additional Information ContactCardinal Health Quality Systems
800-292-9332
Manufacturer Reason
for Recall		The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
FDA Determined
Cause 2		Other
ActionRecalled by salesman visit on 11/15/03 and follow-up faxed letter dated 11/18/03. The hospital was instructed to inspect their inventory for the affected catalog number and work order numbers, segregating them and placing the provided warning labels on the pack. The warnijng labels instruct the user not to use the Namic Angiography Kit attached to the pack and return the kit to Cardinal Health.
Quantity in Commerce1,083 kits
DistributionGeorgia, Alabama
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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