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Device Recall ARROWgard Blue(R) MAC(TM) TwoLumen Central Venous Access Kit
Model / Serial
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
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Product Description
(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
Manufacturer
Arrow International Inc
1 Event
Recall of Device Recall ARROWgard Blue(R) MAC(TM) TwoLumen Central Venous Access Kit
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Manufacturer
Arrow International Inc
Manufacturer Address
Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA
Language
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