Recall Z-2170-2017
Arrow International Inc · initiated April 28, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Codes / lots: 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
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Arrow International sent an Urgent Medical Device Notification letter dated May 2, 2017, to all affected customers to inform them of the issue. The letter will instruct the distributor to notify their customers if the product was further distributed and to return a completed acknowledgement form indicating the amount of units on hand. For further questions, please call (610) 378-0131.
Details
- Recall number
- Z-2170-2017
- Initiated
- April 28, 2017
- Terminated
- August 3, 2018
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 3,918 units
- Distribution
- US Distribution to the state of : NC
- Recalling firm
- Arrow International Inc, Reading, PA