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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and packaging issue (missing stickers) with no reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Arrow International Inc. is recalling 23,904 units of Pressure Injectable Multi-Lumen Central Venous Pressure Injectable ARROW(R) PICC Kits with Chlorag+ard(R) Technology. The recall is due to a labeling defect where some products are 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-45552-RWJ4, 13F16J0286, 13F16L0014, 13F17A0217, 13F17D0222, 13F17E0849, 13F17F0784, and 13F17G0413.
Healthcare facilities and consumers should check their inventory for these specific lot codes and verify that the required labeling stickers are present. If a unit is missing the sticker with the lot number, expiration date, or UDI, it should not be used and should be returned to the manufacturer or disposed of according to local regulations.
The recalled product
- 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…
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 23,904
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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