The Recall Desk
SevereFDA (Devices)·Z-0351-2023·Announced 2022-12-21

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Central Venous Catheters
Hazard
  • connector-defect

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

Distributed in 6 states:

  • FL
  • GA
  • KY
  • OH
  • PA
  • WV

Related recalls

Same category