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U.S. Department of Health and Human Services

Class 2 Device Recall capillary endcaps

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  Class 2 Device Recall capillary endcaps see related information
Date Initiated by Firm March 22, 2006
Date Posting Updated August 03, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1321-06
Recall Event ID 35775
Product Classification accessory for use with blood gas analyzers - Product Code GIO
Product Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.
Code Information Red Caps - Model #904-439 , lot number less than 0535033
Recalling Firm/
Manufacturer
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
800-736-0600
Manufacturer Reason
for Recall
Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.
FDA Determined
Cause 2
Other
Action The firm notified their customers of this recall action with a letter dated 3/22/2006. The letter was accompanied by a single bag of new end caps. The letter informs the customers of the ''leakage'' problem and asks that the customer examine their inventories and discard any of the referenced end caps found on-hand at any of their various locations. The letter also includes a response form to be faxed back to Radiometer indicating the amount of replacement capillary end caps required by the customer in addition to the one bag received. The recalling firm also notified the customers that the suspect end caps will all be replaced ASAP.
Quantity in Commerce Red Caps: 178 kits Each kit contains 1 to 5 bags of caps
Distribution Nationwide, Canada and Istanbul.
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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