SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and e
FDA device recall Z-0975-2007 · posted 2007-07-03 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- The clinitubes are not able to be filled due to contamination with silicone during production.
- Action taken
- 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
- Status
- Terminated
- Product code
- GIO
- Quantity affected
- 175 boxes
- Distribution
- Nationwide and Canada.
- Date initiated
- 2006-06-22
- Date posted
- 2007-07-03
- Date terminated
- 2012-05-08
- Location
- Westlake, OH
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