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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the issue is a documentation and packaging defect (missing stickers) rather than a functional safety hazard or contamination risk.
Plain-English summary
Arrow International Inc is recalling 23,904 units of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS. The recall is due to a documentation issue where some of the products may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
The affected products were distributed in the United States in the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. The specific lot codes associated with this recall are ASK-45703-PRJ, 13F16M0019, 13F17B0343, 13F17D0113, 13F17G0059, and 13F17H0095.
Healthcare facilities and consumers should check their inventory for these specific lot codes and verify that the required labeling stickers are present. If a product is missing the sticker with the lot number, expiration date, or UDI, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- 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
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 23,904
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 (1)
- ASK-45703-PRJ 13F16M0019 13F17B0343 13F17D0113 13F17G0059 13F17H0095
Distribution
Part of a larger recall action
This product is one of 12 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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