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Recall Observatory FDA recall evidence

Device product

Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

Z-2170-2017

April 28, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 77163
Status
Terminated
Classification
Class II
Quantity
3,918 units
Official record key
device-enforcement:Z-2170-2017

Official wording

Reason: Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.

Code information: ASK-04001-DU9 and ASK-04001-DU10 Device Listing Number D156491 Lot Numbers: 23F15L0593 23F16A0300 23F16B0028 23F16B0523 23F16J0151 23F16K0363 23F16K0431 23F16K0820 23F15L0662 23F16A0298 23F16B0338 23F16C0321 23F16C0632 23F16J0105 23F16K0449

Distribution pattern: US Distribution to the state of : NC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.