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Terminated

SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.

FDA Recall Z-0975-2007 · Posted 2007-07-03

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeGIO
Date Initiated2006-06-22
Date Terminated2012-05-08
Product Quantity175 boxes

Reason for Recall

The clinitubes are not able to be filled due to contamination with silicone during production.

Firm Action

The firm notified their customers of this recall with a letter dated 6/22/2006. The letter informs the customers of the problem with the affected lots of SafeCLINITUBES and asks that the customers discard any remaining boxes of affected product on-site. The recall letter is accompanied by a FAX FORM (response form) which the customer is asked to complete in order to request replacement product to be sent to their individual locations.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Official Source

View FDA Recall →

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

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