Z-0544-2007
Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula...
Terumo Cardiovascular Systems Corporation / initiated 2006-12-07 / Terminated
Terumo Cardiovascular Systems Corp began a recall of Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351 on . The reason FDA records is "The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4"". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0544-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351.
- Product code
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Reason for recall
- The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
- FDA root cause
- Other
- Action
- Consignee was notified via telephone on 12/7/06 and returned the product.
- Quantity in commerce
- 10
- Distribution
- Pennsylvania.
- Product codes and lots
- Lot 2119905, exp. October 2009.
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