Arrow PICC Catheters Recalled for Incorrect Expiration Date Labeling
Arrow International is recalling 991 units of Arrow PICC with Chloraguard Technology due to incorrect expiration dates on the product.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling 991 units of Arrow PICC with Chloraguard Technology (Product Code: PR 45541 HPHNM). The recall was initiated because the product was labeled with an incorrect expiration date.
The affected units were distributed nationwide and to foreign markets. The specific batch codes involved in this recall are 13F17C0188, 13F18G0948, and 13R17C0188.
Healthcare providers and consumers should check their inventory for these specific product codes and batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 991
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)
- Batch Code:13F17C0188
- 13F18G0948
- 13R17C0188
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 36 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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