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Terminated

Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

FDA Recall Z-2825-2015 · Posted 2015-09-30

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2015-08-27
Date Terminated2018-06-18
Product Quantity73714

Reason for Recall

Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.

Firm Action

An urgent recall notification letter, dated August 27, 2015, was sent to direct consignees to inform them of the issue and provided instructions for removing the syringes from the kit and returning product along with the response form.

Root Cause

Process control

Distribution Pattern

Nationwide and internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042126PICCArrow Intl., Inc. · 2004-08-27K011761MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc. · 2001-10-31K002507TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc. · 2001-03-21K003006TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTIONArrow Intl., Inc. · 2000-10-27K00158719 GA PLASTIC REINFORCED EPIDURAL CATHETERArrow Intl., Inc. · 2000-07-12

Official Source

View FDA Recall →

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

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