Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm)
FDA device recall Z-0200-06 · posted 2005-11-26 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.
- Action taken
- Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 2520
- Distribution
- Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.
- Date initiated
- 2005-09-12
- Date posted
- 2005-11-26
- Date terminated
- 2006-03-22
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIBLE ARTERIAL CANNULAE (K771499) | 3M Health Care, Sarns | 1977-08-16 |