Arrow ErgoPack central venous catheter recalled for incorrect labeling
ARROW INTERNATIONAL is recalling 180 units of the Arrow ErgoPack Complete CVC catheter (Lot 33F23B0723) distributed in the US because the product code and product name were incorrectly listed on the kit's label.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, the most serious agency classification. FDA Class I recalls carry a minimum severity threshold of 4. The labeling error—listing incorrect product code and name on medical device kits—creates a risk of device mix-up in healthcare settings.
Plain-English summary
ARROW INTERNATIONAL Inc. is recalling 180 units of the Arrow ErgoPack Complete, Pressure Injectable Arrowguard Blue Plus Four-Lumen CVC intravascular catheter (Reference CDC-42854-PCN1A, Lot 33F23B0723) distributed in the United States.
The product code and product name were incorrectly listed on the lidstock (label) of the affected kits. This labeling error affects a medical device intended for long-term intravascular use (greater than 30 days).
Health care facilities that may have received kits from the affected lot should verify the product code and name on their inventory match their records. Customers with questions or who believe they have received affected units should contact ARROW INTERNATIONAL.
The recalled product
- Product
- Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- Affected units
- 180
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 33F23B0723
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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