—#120336

Product

Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K862056
Affected lot / code info: Catalog # AK-17702-CDC, lot # RF2083258

Why it was recalled

Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.

Timeline

Recall initiated: 2013-07-31
Posted by FDA: 2013-08-14
Terminated: 2015-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.