Arrow PICC Set Recalled for Potential Sterility Compromise
Arrow International Inc is recalling 416,055 ARROW PICC Sets because unsealed packaging may compromise product sterility.
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 criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of ARROW PICC Sets, specifically product codes PR-35563-HPHNL and PR-35563-HPHNM. The recall is due to a potential compromise in product sterility caused by unsealed packaging.
The affected products were distributed nationwide in the United States and in numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas. The specific lot numbers involved are 13F17F0445 for product code PR-35563-HPHNL and 13F17K0495 for product code PR-35563-HPHNM.
Healthcare providers and facilities should check their inventory for these specific product codes and lot numbers. If the recalled products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have already received these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — PICC Set
- Affected units
- 416,055
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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