—#161865

Product

Radial Artery Catheterization Kit; Model: AK-04120

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K810675
Affected lot / code info: Lots: 13F16H0289, 13F16M0161, 13F17E0858, 13F17G0178, 23F16E1191, 23F16H0163; Expiration dates: October 2018 through March 2020

Why it was recalled

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Teleflex/Arrow sent a letter dated October 26th, 2017. Customers are instructed to discontinue use and quarantine any products with the affected product codes and lot numbers. There is a Recall Acknowledgment Form that is requested to be completed that will allow the return and replacement of the affected product. Consignees without affected product on hand are also asked to return the form.

Recalling firm

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

Distribution

Distribution pattern: US nationwide distribution, including Puerto Rico.

Timeline

Recall initiated: 2017-10-26
Terminated: 2019-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161865. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.