The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1290-2022·Announced 2022-07-06

Central venous catheter recalled for incorrect gravity flow rates

Arrow International is recalling the Arrow Three-Lumen CVC due to incorrect gravity flow rates on the product lidstock. The defect may affect fluid and medication delivery through the catheter.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall for a functional defect in a critical medical device. No illnesses or injuries have been reported, but the defect could impact drug delivery and patient care, placing it in the category of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc. is recalling the Arrow Three-Lumen CVC, a medical device used for central venous access and fluid or medication administration. Approximately 10,301 units of this catheter are affected.

The recalled catheters contain incorrect gravity flow rates on the product lidstock. This defect may affect the rate at which fluids or medications flow through the catheter via gravity.

The affected units were distributed in Florida. Healthcare facilities with affected lot numbers should review this recall and take appropriate action according to facility protocol and guidance from Arrow International Inc.

The recalled product

Product
Arrow Three-Lumen CVC
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Central Venous Catheter
Hazard
Affected units
10,301

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 (20)

  • Catalog Number: CV-12123-F
  • Lot Numbers: 71F20A0430 [UDI: (01)20801902122838(17)211214(10)71F20A0430]
  • 71F20A2583 [UDI: (01)20801902122838(17)250103(10)71F20A2583]
  • 71F20B0793 [UDI: (01)20801902122838(17)250115(10)71F20B0793]
  • 71F20B2188 [UDI: (01)20801902122838(17)250204(10)71F20B2188]
  • 71F20C1356 [UDI: (01)10801902136944(17)220630(10)71F20C1356]
  • 71F20D1047 [UDI: (01)20801902122838(17)250402(10)71F20D1047]
  • 71F20E2225 [UDI: (01)20801902122838(17)250531(10)71F20E2225]
  • 71F20G2376 [UDI: (01)20801902122838(17)250701(10)71F20G2376]
  • 71F20K0771 [UDI: (01)20801902122838(17)241130(10)71F20K0771]
  • 71F20K2265 [UDI: (01)20801902122838(17)250228(10)71F20K2265]
  • 71F20L0567 [UDI: (01)20801902122838(17)250228(10)71F20L0567]
  • 71F20M1262 [UDI: (01)20801902122838(17)250331(10)71F20M1262]
  • 71F21B0849 [UDI: (01)10801902179514(17)250430(10)71F21B0849]
  • 71F21B0850 [UDI: (01)20801902122838(17)250430(10)71F21B0850]
  • 71F21B2430 [UDI: (01)20801902122838(17)250430(10)71F21B2430]
  • 71F21C0637 [UDI: (01)20801902122838(17)250331(10)71F21C0637]
  • 71F21C0964 [UDI: (01)10801902170856(17)260214(10)71F21C0964]
  • 71F21D0025 [UDI: (01)20801902122838(17)250430(10)71F21D0025]
  • 71F21E0586 [UDI: (01)20801902122838(17)250430(10)71F21E0586]

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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