Z-1290-2022Class II

Arrow Three-Lumen CVC

Name: Z-1290-2022 Arrow Three-Lumen CVC
Creator: ARROW INTERNATIONAL Inc.
Published: 2022-05-05
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2022-05-05 / Terminated / root cause: labeling and UDI

FDA source

ARROW INTERNATIONAL Inc. began a recall of Arrow Three-Lumen CVC on 2022-05-05. FDA classified it as Class II and gives the reason as "Gravity flow rates on the affected product lidstock are incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1290-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-05
Posted: 2022-06-27
Terminated: 2024-09-04
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Three-Lumen CVC
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Gravity flow rates on the affected product lidstock are incorrect.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same.
Quantity in commerce: 10,301 units
Distribution: US Nationwide distribution in the states of Florida.
Product codes and lots: 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], 71F21E1030 [UDI: (01)20801902122838(17)250430(10)71F21E1030], 71F21E2583 [UDI: (01)20801902122838(17)250430(10)71F21E2583], 71F21F1156 [UDI: (01)20801902122838(17)250430(10)71F21F1156], 71F21J0698 [UDI: (01)20801902122838(17)250430(10)71F21J0698]

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1290-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1290-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-27

Product code FOZ

K970864Class IIArrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. / cleared 1997-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)