—#162549

Product

(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K810675
Affected lot / code info: Lot Numbers: (1) 13F17D0198, 13F17F0215; (2) 13F17E0029, 13F17E0537; (3) 13F17B0226, 13F17D0017, 13F17D0280; (4) 13F17A0122, 13F17C0342, 13F17E0364, 13F17E0827

Why it was recalled

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Root cause (FDA determination)

Process control

Action the firm took

The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.

Recalling firm

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

Distribution

Distribution pattern: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Timeline

Recall initiated: 2017-12-22
Terminated: 2020-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.