Arrow Medical Kits Recalled for Incorrect Biopatch Dressing Size
Arrow International Inc. is recalling specific medical kits because they were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 source text explicitly states that no risk to patients is anticipated, and the issue is a packaging error (incorrect size) rather than a functional safety defect or contamination.
Plain-English summary
Arrow International Inc. is recalling certain Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC), and Arterial Catheterization Kit (NA) with Biopatch Dressing. The recall involves 4,484 units distributed nationwide in the United States and Puerto Rico.
The recall was initiated because the affected kits were packaged with the incorrect size Biopatch Dressing. The source text explicitly states that no risk to patients is anticipated.
Healthcare providers and consumers should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the product is found, it should be returned to the supplier or the manufacturer for credit or replacement.
The recalled product
- Product
- Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 4,484
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)
- Product Codes: ASK-11142-MGH4
- ASK-04020-UR1
- CDC-45552-HPK1A
- CDC-35052-VPS
- ASK-09903-MGH3
- CDC-02041-MK1A
- CDC-45041-VPS
- ASK-09903-FAM
- CDC-05052-HPK1A
- NA-04020-X1A
- CDC-21242-X1A
- ASK-04020-MI
- ASK-04001-UOC
- MSO-45703-AHS
- CDC-45541-HPK1A
- CDC-35052-HPK1A
- ASK-21142-SG1
- MSO-24703-AHS
- MSO-29802-AHS
- ASK-12702-SMCC
Distribution
Distributed nationwide across the United States.
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