Agency classClass IOur severity:Severe FDA (Devices)·Z-1830-2012·Announced 2012-07-04

Arrow Central Venous Catheter Recall for Labeling Inconsistency

Arrow International is recalling 634,912 central venous catheter sets because the product label states 'contains no medication' while the insert indicates the product is medicated.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status."

Plain-English summary

Arrow International Inc is recalling 634,912 units of Arrow Two-Lumen Central Venous Catheterization Sets with Blue FlexTip ARROWgard Blue Catheter. The recall was initiated due to a labeling discrepancy where the product lidstock does not contain the chlorhexidine contraindication and includes the wording "contains no medication," whereas the product insert reflects the medicated status of the device.

The affected products were distributed worldwide, including the United States and numerous international markets. The recall covers various part numbers and specific lot numbers listed in the agency's documentation.

Healthcare providers and consumers should check their inventory for the specific part numbers and lot numbers identified in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or distributor in accordance with the recall instructions.

The recalled product

Product: Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
Manufacturer: Arrow International Inc
Category: Medical Device — Central Venous Catheter
Hazard: mis-labeling
Affected units: 634,912

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part numbers (PN) AD-24703 -- lots ZF0088927
ZF0099619
ZF0099893
ZF0100764
ZF0111386
ZF0112205
ZF1013500
ZF1024535
ZF1025078
ZF1036034
ZF1036293
ZF1047553
ZF1068055
ZF1079398
ZF1080286
ZF1091018
ZF1102643
ZF1103235
ZF1113530
ZF1114129

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Arrow International Inc

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Same hazard · mis labeling