Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

FDA Recall Z-2771-2016 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2016-02-17
Date Terminated2017-10-18
Product Quantity6,121 units in total

Reason for Recall

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Firm Action

The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to [email protected], even if you do not have no affected product. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Distribution to states of: NC, OH, FL, and MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061289ARROW PRESSURE INJECTABLE PICCArrow International, Inc. · 2006-08-24

Official Source

View FDA Recall →

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

↑