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Terminated

ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

FDA Recall Z-0601-2018 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2017-07-25
Date Terminated2018-08-29
Product Quantity2691 total

Reason for Recall

Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

Firm Action

Arrow International notified all U.S. consignees with letter sent on July 25, 2017, via FedEx 2-day. second notification August 22, 2017, third notification November 28, 2017.

Root Cause

Packaging process control

Distribution Pattern

US nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121941ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.) · 2012-09-07

Official Source

View FDA Recall →

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

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