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Recall Observatory FDA recall evidence

Device product

(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

Z-1324-2018

December 22, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79512
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1324-2018

Official wording

Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information: Lot Numbers: (1) 13F16L0254, 13F17B0196, 13F17C0046; (2) 13F17D0212, 13F17E0770, 13F17F0438; (3) 13F17E0656, 13F17F0188, 13F17F0459; (4) 13F17B0139, 13F17B0140, 13F17B0141, 13F17B0142, 13F17D0131, 13F17D0141, 13F17E0509, 13F17E0510, 13F17E0867, 13F17F0439; (5) 13F17C0339, 13F17E0230, 13F17E0718; (6) 13F16L0179, 13F17E0042, 13F17E0231, 13F17E0411, 13F17E0836

Distribution pattern: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.