Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571.
This recall has been terminated (originally issued July 10, 2007).
- Recall Initiated
- May 22, 2007
- Posted
- July 10, 2007
- Terminated
- July 7, 2009
- Recall Number
- Z-0878-2007
- Quantity
- 129
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
Distribution
Nationwide.
Lot / Code Info
Lot 2120266.
Root Cause
Other
Action Taken
Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.
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