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Terminated

Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

FDA Recall Z-2269-2017 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2017-03-20
Date Terminated2018-12-18
Product Quantity43,394 units

Reason for Recall

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Firm Action

Arrow International sent an Urgent Medical Device Notification Letter dated April 5, 2017, to affected customers to inform them of the issue. The notice provided safety instructions for using the product and instructed customers to return the enclosed acknowledgement form indicating the notice was received, and fax it to 855-419-8507, Attn: Customer Service or email to [email protected]. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002507TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc. · 2001-03-21

Official Source

View FDA Recall →

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

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