Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps

FDA device recall Z-1322-06 · posted 2006-08-03 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

GIO

Quantity affected

Green Caps: 208 kits. Each kit contains 1 to 5 bags of caps.

Distribution

Nationwide, Canada and Istanbul.

Date initiated

2006-03-22

Date posted

2006-08-03

Date terminated

2012-02-24

Location

Westlake, OH