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.
- Company
- Arrow International Inc.
- Recall Initiated
- July 26, 2024
- Posted
- September 26, 2024
- Recall Number
- Z-3299-2024
- Quantity
- 14,845 kits
- Firm Location
- Morrisville, NC
Reason for Recall
Reports have been received regarding open seals on the packaging.
Distribution
US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.
Lot / Code Info
(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.
Root Cause
Nonconforming Material/Component
Action Taken
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.