Arrow International Recalls Arterial Catheterization Kits Due to Sterility Concerns
Arrow International Inc is recalling specific lots of arterial catheterization kits because the products may not be completely sealed, meaning sterility cannot be guaranteed.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (infection) from a lack of sterility, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling four specific types of arterial catheterization kits and arterial line kits. The affected products include the Arterial Catheterization Kit (PN: ASK-04018-CC), Arterial Line Kit with Sharps Safety Features (PN: ASK-04510-HUM), Arterial Line Kit with Sharps Safety Features (PN: ASK-04550-UHC), and Arterial Catheterization Kit (PN: NA-04550-X1A). The recall involves specific lot numbers: 13F17D0198, 13F17F0215, 13F17E0029, 13F17E0537, 13F17B0226, 13F17D0017, 13F17D0280, 13F17A0122, 13F17C0342, 13F17E0364, and 13F17E0827.
The recall is being conducted because certain lots of these cardiovascular catheters may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.
The affected products were distributed in all 50 U.S. states and the District of Columbia, as well as in the Bahamas, Canada, Mexico, Panama, and Singapore. Healthcare facilities and consumers should check their inventory for the specific part numbers and lot numbers listed above. If these products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
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 (11)
- Lot Numbers: (1) 13F17D0198
- 13F17F0215
- (2) 13F17E0029
- 13F17E0537
- (3) 13F17B0226
- 13F17D0017
- 13F17D0280
- (4) 13F17A0122
- 13F17C0342
- 13F17E0364
- 13F17E0827
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 14 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 14 products in this recall →Related recalls
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