ARROW recallZ-3299-2024 · ARROW INTERNATIONAL Inc. · initiated Jul 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ARROW INTERNATIONAL Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reports have been received regarding open seals on the packaging.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued letters dated July-2024 via Fed Ex 2-day mail on 7/26/2024. The letter provided a description of the problem and immediate actions required. Medical facilities were requested to immediately check their inventory for the affected product and cease use and distribution of it. The product is to be quarantined immediately. If the facility has the impacted product, they are to indicate so on the Acknowledgement Form enclosed with the letter and FAX it to the firm. A customer service representative will contact the medical facility with a Return Goods Authorization (RGA) Number and provide instructions for the return of the product. Distributors are requested to provide the field safety notice to all customers who have received the impacted product. Each of the distributor's customers are required to complete the Acknowledgment Form and return it to the distributor. Additionally, the distributor is to check their inventory for the impacted product, cease use and distribution of it, and quarantine it. If the product has been further distributed outside of the distributor's country, they are to notify Teleflex Customer Service by return email.
Recall details
- Recall number
- Z-3299-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 26, 2024
- Posted by the FDA
- Sep 26, 2024
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 14,845 kits
- Product code
- DQX
- FDA submissions
- K810675, K914531
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.
Product description
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
(1) REF ASK-04001-BW1: Batch numbers 33F23M0157, 33F24C0002, 33F24C0136, and 33F23L0297, UDI-DI: 10801902117585; (2) REF ASK-04001-CK: Batch numbers 33F24A0390, 33F24B0233, 33F24A0260, 33F24A0036, and 33F23L0738, UDI-DI: 00801902091215; (3) REF ASK-04001-VAMC1: Batch numbers 33F24A0825 and 33F24B0235, UDI-DI: 10801902158854; (4) REF ASK-04020-BHS: Batch numbers 33F24C0678, 33F23K0881, 33F24B0788, 33F24A1676, 33F24A0711, and 33F23L0687, UDI-DI: 30801902144578; (5) REF ASK-04020-BID: Batch number 33F23J0777, UDI (1)10801902211429(17)260331(10)33F23J0777; (6) REF ASK-04020-HMC: Batch numbers 33F24A0743, 33F23L0747, and 33F24A1129, UDI-DI: 10801902117691; (7) REF ASK-04020-HOA: Batch number 33F24D0969, UDI: (1)10801902214802(17)251124(10)33F24D0969; (8) REF ASK-04020-KSD: Batch number 33F24D0964, UDI: (1)10801902219630(17)251130(10)33F24D0964; (9) REF ASK-04020-LOL: Batch numbers 33F24A1135, 33F24B0254, 33F24A0731, 33F24A0314, and 33F23M0033, UDI-DI 10801902144765; (10) REF ASK-04020-MHS: Batch numbers 33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, and 33F23L0734, UDI-DI 20801902117711(17)260426; (11) REF ASK-04020-MIB3: Batch number 33F24A0901, UDI (1)10801902206401(17)250831(10)33F24A0901; (12) REF ASK-04020-PRH: Batch number 33F23K0602, UDI (1)10801902155938(17)250731(10)33F23K0602; (13) REF ASK-04020-UOIL: Batch number 33F24B0001, UDI (1)10801902218978(17)261031(10)33F24B0001; (14) REF ASK-04220-KSP: Batch number 33F23L0323, UDI (1)10801902156409(17)250531(10)33F23L0323; and (15) REF ASK-04500-HFH4: Batch numbers 33F24C0436, 33F24A0617, and 33F23K1006, UDI-DI 10801902200461.
Devices named in this recall
15 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARROW IPN036829Teleflex Incorporated · Wire, guide, catheter3 recalls1 report
- ARROW IPN055732Teleflex Incorporated · Needle, hypodermic, single lumen3 recalls0 reports
- ARROW IPN036983Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls6 reports
- ARROW IPN036992Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN038976Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN055557Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN921748Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN925200Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN029798Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN032685Teleflex Incorporated · WIRE, GUIDE, CATHETER1 recall0 reports
- ARROW IPN055250Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN923350Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN927641Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN929241Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN929479Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
Product lines
Other devices under the same FDA submission
110 devices cleared under K810675, K914531 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
- ARROW IPN037007Teleflex Incorporated · WIRE, GUIDE, CATHETER3 recalls2 reports
- ARROW IPN037256Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls2 reports
- ARROW IPN036999Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls1 report
- ARROW IPN037023Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037000Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN036853Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037005Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN036981Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037006Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037163Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page