Z-2170-2017 Class II Terminated
FDA device recall Z-2170-2017 was initiated by Arrow International Inc on April 28, 2017 and is designated Class II. Reason for recall: 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. Secu… The recall status is terminated (terminated August 3, 2018). Affected quantity: 3,918 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- April 28, 2017
- Termination Date
- August 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,918 units
Product Description
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Reason for Recall
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.
Distribution Pattern
US Distribution to the state of : NC
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