Arrow International Recalls Multi-Lumen CVC Kits Due to Missing Instructions
Arrow International Inc is recalling 420 Multi-Lumen PI CVC Kits and PSI Kits because the Instructions for Use were inadvertently removed from the packaging.
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 classified as Low severity because it involves a documentation issue (missing instructions) with no reported injuries, illnesses, or direct physical hazards to the patient.
Plain-English summary
Arrow International Inc is voluntarily recalling 420 units of Multi-Lumen PI CVC Kits and PSI Kits. The recall involves specific lots of 3-Lumen 7 FR X 8 inch catheters and 8.5 FR X 4-1/8 inch catheter introducers. The distribution was limited to the state of Kentucky.
The reason for the recall is that the Instructions for Use (IFU) were inadvertently removed from the kits. The IFU is a critical document that provides necessary guidance for the safe and proper use of the medical device.
Healthcare facilities and consumers who possess these specific products should stop using them immediately. They should contact Arrow International Inc to arrange for the return or replacement of the affected kits. The recall number for this action is Z-1005-2015.
The recalled product
- Product
- Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 420
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 (4)
- exp. 31-Jul-2015 PSI Kit: 8.5 FR X 4-1/8 (10 CM)
- product code ASK-09803-OSU2
- lot #23F14C1014
- exp. 31-Aug-2015:
Distribution
Distributed in 1 state:
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