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Terminated

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.

FDA Recall Z-1321-06 · Posted 2006-08-03

Recall StatusTerminated
Product CodeGIO
Date Initiated2006-03-22
Date Terminated2012-02-24
Product QuantityRed Caps: 178 kits Each kit contains 1 to 5 bags of caps

Reason for Recall

Capilliary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Canada and Istanbul.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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