FDA (Devices) recall action 79339

Arrow International Inc recalled 12 products on 2018-03-21

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2018-03-21
Critical: 0
Units: 286,848

Why these products were recalled

Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–12 of 12

LowFDA (Devices)··2018-03-21
Arrow PICC Kits Recalled for Missing Lot and Expiration Labels
Arrow International is recalling 23,904 PICC kits because some units are missing stickers with lot numbers, expiration dates, and UDI information.
Product
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central v
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls Central Venous Catheter Kits Due to Missing Labels
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.
Product
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venou
Category
Distribution
7 states
ModerateFDA (Devices)··2018-03-21
Arrow CVC Kit Recall for Missing Lot and UDI Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.
Product
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple i
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls CVC Kits Missing Lot Number Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, and UDI information.
Product
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
Category
Distribution
7 states
ModerateFDA (Devices)··2018-03-21
Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.
Product
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access i
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls CVC Kits Missing Lot and UDI Information
Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.
Product
AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluid
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls CVC Kits Missing UDI Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.
Product
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls CVC Kits Missing Lot and UDI Stickers
Arrow International Inc. is recalling 23,904 Arrowg+ard BLUE PLUS CVC Kits because some units are missing stickers containing lot numbers, expiration dates, and UDI information.
Product
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls Arrowg+ard Blue Catheters Due to Missing Labels
Arrow International Inc. is recalling 23,904 Arrowg+ard Blue central venous catheters because some units are missing stickers with lot, expiration, and UDI information.
Product
ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemothera
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls CVC Kits Missing Lot Number Stickers
Arrow International is recalling 23,904 Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kits because some units may be missing stickers containing lot numbers, expiration dates, and UDI information.
Product
ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fl
Category
Distribution
7 states
ModerateFDA (Devices)··2018-03-21
Arrow Central Venous Catheter Kits Recalled for Missing Label Information
Arrow International is recalling 23,904 central venous catheter kits because some units may be missing stickers with lot, expiration, and UDI information.
Product
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases
Category
Distribution
7 states
LowFDA (Devices)··2018-03-21
Arrow International Recalls Central Venous Access Kits Due to Missing Labels
Arrow International is recalling 23,904 central venous access kits because some units may be missing stickers with lot numbers, expiration dates, and UDI information.
Product
ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infus
Category
Distribution
7 states