Device product
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Z-1507-2014
Product summary
- Event
- Event 67834
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170
- Official record key
device-enforcement:Z-1507-2014
Official wording
Reason: Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM
Code information: lot RF2110924
Distribution pattern: US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
Derived failure modes
-
Unknown
Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM