Arrow MAC Two-Lumen Central Venous Access Kit connector housing defect
ARROW INTERNATIONAL is recalling Arrow MAC Two-Lumen Central Venous Access Kits due to potential inadequate connection between the top and bottom housings of included Micro Clave Clear Connectors.
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: FDA Class I classification applies. Although no illnesses or injuries have been reported, the rule requires that FDA Class I recalls score at minimum 4 (Severe), as the potential defect involves a critical medical device component.
Plain-English summary
ARROW INTERNATIONAL Inc. is recalling the Arrow MAC Two-Lumen Central Venous Access Kit (REF ASK-11242-UPM1) due to a potential defect in the Micro Clave Clear Connectors included in the kit. There is a potential for inadequate connection between the top and bottom housings of these connectors.
Affected units include 80 units with Lot Number 13F22C0349 distributed to medical facilities in Florida, Georgia, Kentucky, Ohio, Pennsylvania, and West Virginia.
The FDA classified this as a Class I recall. Healthcare providers and patients who may have this product should contact ARROW INTERNATIONAL or their distributor for further information regarding the recall.
The recalled product
- Product
- Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- Affected units
- 80
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 (2)
- UDI/DI 10801902159448
- Lot Number 13F22C0349
Distribution
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.
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