Arrow PICC Kit Recalled for Incorrect Expiration Date on Lidstock
Arrow International is recalling specific lots of PICC kits because the lidstock displays the wrong expiration date.
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/packaging issue (incorrect expiration date on lidstock) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Arrow International Inc is recalling the Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm (EU-05052-HPMSB). The recall is limited to Lot Number 13F18G0925. The product is being recalled because the lidstock contains the incorrect expiration date for the product.
The affected products were distributed nationwide and in foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA. The source text does not specify the number of units affected or report any illnesses or injuries.
Healthcare facilities and consumers should check their inventory for this specific lot number and expiration date discrepancy. The source text does not provide specific instructions for disposal or replacement, so users should contact the manufacturer or their supplier for further guidance.
The recalled product
- Product
- Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — PICC Kit
- Hazard
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)
- Lot Number: 13F18G0925
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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.
See all 20 products in this recall →Related recalls
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