Arrow PICC with Chloraguard Technology Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 983 units of Arrow PICC with Chloraguard Technology due to incorrect expiration dates.
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 for a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling 983 units of Arrow PICC with Chloraguard Technology (Product Code: PR 45541 HPHNL). The recall was initiated because the product was labeled with an incorrect expiration date.
The affected units are identified by the following batch codes: 13F17A0165, 13F17D0327, 13F18A0208, 13F18B0457, and 13F18F0416. The products were distributed nationwide and to foreign markets.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should check their inventory for the specific batch codes listed above and contact the manufacturer for further instructions.
The recalled product
- Product
- Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45541 HPHNL
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 983
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 (5)
- Batch Code:13F17A0165
- 13F17D0327
- 13F18A0208
- 13F18B0457
- 13F18F0416
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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