Arrow Arterial Kits and Trays as follows: (1) Arrow Arte... (ARROW INTERNATIONAL Inc.) – reports have been received regarding ... (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 Catheteri
Brand
ARROW INTERNATIONAL Inc.
Lot Codes / Batch Numbers
(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.
Products Sold
(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.
ARROW INTERNATIONAL Inc. is recalling Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Gu due to Reports have been received regarding open seals on the packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports have been received regarding open seals on the packaging.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026