—#155518

Product

1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K780532
Affected lot / code info: Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883

Why it was recalled

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Root cause (FDA determination)

Packaging

Action the firm took

Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Canada

Timeline

Recall initiated: 2017-05-09
Terminated: 2018-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155518. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.