Z-1981-2014 Class I Terminated
FDA device recall Z-1981-2014 was initiated by Vascular Solutions, Inc. on May 27, 2014 and is designated Class I. Reason for recall: The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece fro… The recall status is terminated (terminated January 30, 2015). Affected quantity: 8,580 total (US 5714).
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2014
- Initiation Date
- May 27, 2014
- Termination Date
- January 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,580 total (US 5714)
Product Description
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
Reason for Recall
The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
Distribution Pattern
Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
Code Information
Lot Numbers: 569436, 569437, 569962, , 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.