The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0352-2023·Announced 2022-12-21

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.

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 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.
Category
Medical Device — Central Venous Catheter
Hazard
Affected units
1,275

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:

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 →

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