Arrow PICC Sets Recalled Due to Potential Sterility Compromise
Arrow International Inc is recalling 416,055 PICC sets because unsealed packaging may have compromised 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 (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria.
Plain-English summary
Arrow International Inc is recalling 416,055 ARROW PICC Sets because product sterility may be compromised due to unsealed packaging. The recall includes specific product codes and lot numbers distributed in the United States and numerous international locations.
The affected products are medical devices used for intravenous access. The recall is driven by a potential defect in the packaging integrity, which could allow the product to lose its sterile status. No specific illnesses or injuries are reported in the source text.
Healthcare facilities and consumers should stop using the affected PICC sets and contact Arrow International Inc for further instructions or replacement.
The recalled product
- Product
- ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
- Manufacturer
- Arrow International Inc
- 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.
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