Arrow PSI Kit Recall Due to Potential Sterility Compromise
Arrow International is recalling 416,055 PSI kits because unsealed packaging may have compromised sterility. The recall covers products distributed in the US and 34 other countries.
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 involves a medical device where sterility may be compromised, posing a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of the ARROWg+ard Blue PSI Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters (Product code SF-29803-1). The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products are identified by Lot Numbers 13F17C0004 and 13F17G0030. These kits were distributed in the United States and internationally, including Australia, Austria, Belgium, Canada, and 30 other countries listed in the recall notice.
Healthcare facilities and consumers should stop using these specific kits and contact Arrow International Inc. for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
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 Numbers: 13F17C0004 13F17G0030
Distribution
Part of a larger recall action
This product is one of 76 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 76 products in this recall →Related recalls
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