—#155122

Product

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

FDA product code: OBJ — Catheter, Ultrasound, Intravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K103255
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: US Distribution to the state of : NC

Timeline

Recall initiated: 2017-04-28
Terminated: 2018-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155122. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.