Arrow International Recalls PICC Catheter Trimmers Due to Packaging Defects
Arrow International is recalling 416,055 PICC Catheter Trimmers because unsealed packaging may compromise product sterility. The recall covers units 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, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of PICC Catheter Trimmers (Product Code: PC-00001-T). The recall is being conducted because the product sterility may be compromised due to unsealed packaging. The affected lot numbers are 13F17C0349 and 13F17F0300.
The recalled products were distributed nationwide in the United States as well as in 34 other countries, including Australia, Canada, the United Kingdom, and Germany. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected PICC Catheter Trimmers and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- PICC Catheter Trimmer ; Product Code:PC-00001-T
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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: 13F17C0349 13F17F0300
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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