Arrow PICC Kit Recall Due to Potential Sterility Seal Failure
Arrow International is recalling specific lots of ARROW PICC Kits because the seals may not be completely closed, meaning the product's 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. The hazard involves a potential breach of sterility in a medical device, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling certain lots of Pressure Injectable ARROW(R) PICC Kits with Chlorag+ard Technology. The affected part numbers are ASK-45541-RWJ4 and ASK-45552-RWJ4. The specific lot numbers involved are 13F17D0187, 13F17D0222, and 13F17E0849.
The recall was initiated because the cardiovascular catheters in these kits may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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 providers and facilities should check their inventory for these specific part and lot numbers and stop using the affected kits. Consumers should contact their healthcare provider if they have questions regarding the use of these products.
The recalled product
- Product
- Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
- Manufacturer
- Arrow International Inc
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 (3)
- Lot Numbers: (1) 13F17D0187
- (2) 13F17D0222
- 13F17E0849
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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