Arrow ErgoPack PICC catheter kits recalled for incorrect product labeling
Arrow International recalled 177 ErgoPack PICC catheter kits because the product code and name were incorrectly listed on the packaging. No illnesses or injuries reported.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a labeling and packaging-only issue with no reported illnesses, injuries, or adverse events. The product itself is not defective; only the product code and name on the outer packaging label are incorrect. Per the FDA severity rubric, packaging-only problems and documentation issues are classified as Low severity.
Plain-English summary
Arrow International Inc. is recalling 177 units of Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet (model CDC-35552-VPS). This medical device is used for long-term intravenous catheter access.
The recall was initiated due to reports that the product code and product name were incorrectly listed on the lidstock (outer packaging label) of the affected kits.
These affected units were distributed nationwide in the United States under batch/lot number 13F22E0359.
No illnesses, injuries, or adverse events have been reported related to this labeling error.
The recalled product
- Product
- Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Affected units
- 177
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)
- Batch/Lot number 13F22E0359
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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