Central Venous Catheter Kits Recalled for Potential Connector Housing Failure
ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.
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 medical device recall. Although no illnesses or deaths have been reported, FDA Class I classification mandates a minimum severity score of 4 (Severe), as it indicates serious potential for harm. The defect involves a critical connector component in a central venous catheter system.
Plain-English summary
ARROW INTERNATIONAL Inc. is recalling 1,275 units of the Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kit and related kits containing Micro Clave Clear Connectors. The recalled units carry reference numbers ASK-42703-NS, ASK-42703-PCCH2, ASK-42703-PUPM1, ASK-45703-NS, ASK-45703-PAU, ASK-45703-PCAM1, ASK-45703-PCCH2, and ASK-45703-PN.
The FDA identified a potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in these kits. An inadequate connection could result in connector failure or improper function of the catheter system during clinical use.
The recalled units were distributed through a medical supplier to healthcare facilities in Florida, Georgia, Kentucky, Ohio, Pennsylvania, and West Virginia.
Healthcare providers and hospitals using these kits should immediately remove them from service. Contact ARROW INTERNATIONAL Inc. or your medical supplier for replacement or return instructions. Report any adverse events or patient injuries to the FDA MedWatch program.
The recalled product
- Product
- Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- connector-housing-defect
- device-malfunction
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 (9)
- a) ASK-42703-NS: UDI/DI 10801902162905
- Lot Numbers: 13F22B0495 b) ASK-42703-PCCH2: UDI/DI 10801902141030
- Lot Numbers: 13F22C0862 c) ASK-42703-PUPM1: UDI/DI 10801902159592
- Lot Numbers: 13F22B0021 d) ASK-45703-NS: UDI/DI 10801902162912
- Lot Numbers: 13F22C0244 e) ASK-45703-PAU: UDI/DI 10801902159110
- Lot Numbers: 13F22D0121 f) ASK-45703-PCAM1: UDI/DI 10801902203158
- Lot Numbers: 13F22C0553 g) ASK-45703-PCCH2: UDI/DI 10801902141047
- Lot Numbers: 13F22B0641 h) ASK-45703-PN: UDI/DI 10801902140675
- Lot Numbers: 13F22C0350
Distribution
Distributed in 6 states:
- FL
- GA
- KY
- OH
- PA
- WV
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