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Terminated

Radial Artery Catheterization Kit; Model: AK-04020

FDA Recall Z-1282-2018 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQX
Date Initiated2017-10-26
Date Terminated2019-12-10
Product Quantity50,263

Reason for Recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Firm Action

Teleflex/Arrow sent a letter dated October 26th, 2017. Customers are instructed to discontinue use and quarantine any products with the affected product codes and lot numbers. There is a Recall Acknowledgment Form that is requested to be completed that will allow the return and replacement of the affected product. Consignees without affected product on hand are also asked to return the form.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US nationwide distribution, including Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K810675ARROW RADIAL ARTERY CATHETERIZATION SETArrow Intl., Inc. · 1981-03-27

Official Source

View FDA Recall →

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

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