Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Lot 2120262.
Products Sold
Lot 2120262.
Terumo Cardiovascular Systems Corp is recalling Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 in due to 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).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026