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Terminated

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 Recall Z-2329-2017 · Posted None

Recall StatusTerminated
Product CodeDYB
Date Initiated2017-05-09
Date Terminated2018-09-17
Product Quantity27,485 units distributed in U.S, 4,371 units distributed internationally

Reason for Recall

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

Firm Action

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.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution - US (nationwide) and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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