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U.S. Department of Health and Human Services

Class 1 Device Recall ARROW QuickFlash

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  Class 1 Device Recall ARROW QuickFlash see related information
Date Initiated by Firm February 12, 2024
Date Posted March 21, 2024
Recall Status1 Open3, Classified
Recall Number Z-1267-2024
Recall Event ID 94033
510(K)Number K160018  
Product Classification Wire, guide, catheter - Product Code DQX
Product ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:
a) REF AK-04220;
b) REF ASK-04220-FMH1;
c) REF ASK-04220-HHC;
d) REF ASK-04220-KSP;
e) REF ASK-04220-PSU;
f) REF ASK-04220-UCL1;
g) REF ASK-04500-AH;
h) REF ASK-04500-HF-S;
i) REF NA-04220-S1A;
j) REF NA-04220-X1A;
k) REF RA-04220;
l) REF RA-04220-W
Code Information a) REF AK-04220, UDI/DI 20801902190943, Lot Numbers: 13F22E0436, 13F22H0360, 33F23E0375, 33F23K0032, 33F23J0443, 33F23L0862; UDI/DI 30801902121616, Lot Numbers: 13F22L0105, 13F23A0651, 33F23C0100, 33F23F0347, 33F23E0501, 33F23G0141; b) REF ASK-04220-FMH1, UDI/DI 20801902111665, Lot Numbers: 33F23B0525, 33F23H0100; c) REF ASK-04220-HHC, UDI/DI 20801902190851, Lot Numbers: 33F23F0067, 33F23K0278, 33F23G0478, 33F23H0101; d) REF ASK-04220-KSP, UDI/DI 20801902156406, Lot Numbers: 33F23E0709, 33F23H0102, 33F23H0918, 33F23J0607; e) REF ASK-04220-PSU, UDI/DI 40801902121446, Lot Numbers: 33F23F0331, 33F23G0663; f) REF ASK-04220-UCL1, UDI/DI 20801902159124, Lot Numbers: 33F23F0801, 33F23C0726, 33F23H0320; g) REF ASK-04500-AH, UDI/DI 20801902114048, Lot Numbers: 33F23E0731, 33F23H0103, 33F23H0395; h) REF ASK-04500-HF-S, UDI/DI 40801902118002, Lot Numbers: 33F23F0202, 33F23H0104, 33F23H0396; i) REF NA-04220-S1A, UDI/DI 20801902139416, Lot Numbers: 33F23J0671; j) REF NA-04220-X1A, UDI/DI 20801902136606, Lot Numbers: 33F23F0704; k) REF RA-04220, UDI/DI 20801902180678, Lot Numbers: 14F23B0041; UDI/DI 30801902193309, Lot Numbers: 14F21L0189, 14F21L0190, 14F21L0250, 14F21L0251, 14F21L0252, 14F21L0253, 14F21M0130, 14F21M0131, 14F21M0205, 14F21M0206, 14F22A0044, 14F22A0123, 14F22A0124, 14F22A0143, 14F22A0144, 14F22B0163, 14F22B0164, 14F22B0175, 14F22C0017, 14F22C0018, 14F22C0019, 14F22C0020, 14F22C0021, 14F22C0022, 14F22C0216, 14F22C0284, 14F22C0346, 14F22C0347, 14F22D0023, 14F22D0024, 14F22D0110, 14F22D0217, 14F22D0291, 14S22D0218, 14F22E0016, 14F22E0173, 14F22E0215, 14F22F0003, 14F22F0062, 14F22F0208, 14F22F0209, 14F22F0210, 14F22F0212, 14F22F0335, 14F22F0336, 14F22G0297, 14F22G0298, 14F22G0325, 14F22G0326, 14F22H0078, 14F22H0079, 14F22H0250, 14F22J0078, 14F22J0079, 14F22J0080, 14F22J0081, 14F22J0082, 14F22J0083, 14F22J0257; UDI/DI 30801902210631, Lot Numbers: 14F22K0182, 14F22K0183, 14F22K0184, 14F22K0185, 14F22K0223, 14F22M0032, 14F22M0033, 14F22M0034, 14F22M0035, 14F22M0036, 14F22M0132, 14F23B0042, 14F23B0142, 14F23B0143, 14F23B0144, 14F23B0154, 14F23D0203, 14F23D0204, 14F23D0205, 14F23D0206, 14F23D0207, 14F23E0093, 14F23E0094, 14F23E0210, 14F23E0211, 14F23F0036, 14F23F0037, 14F23F0038, 14F23F0252, 14F23F0253, 14F23F0377, 14F23F0378, 14F23F0379, 14F23G0147, 14F23G0148, 14F23G0149, 14F23G0150, 14F23G0151, 14F23G0252, 14F23H0087, 14F23H0088, 14F23H0089, 14F23H0090, 14F23H0163, 14F23H0253, 14F23H0254, 14F23H0255, 14F23J0031, 14F23J0032, 14F23J0137, 14F23J0138, 14F23J0276, 14F23J0277; l) REF RA-04220-W, UDI/DI 30801902193316, Lot Numbers: 13F22E0142, 13F22H0417, 13F22J0586, 13F22M0442, 13F23C0015, 13F23J0017; UDI/DI 30801902202988, Lot Numbers: 13F22F0124, 13F23B0363, 13F23H0010, 13F23J0013, 13F23K0001
Recalling Firm/
Manufacturer		 ARROW INTERNATIONAL Inc.
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
FDA Determined
Cause 2		 Process control
Action Teleflex/ARROW INTERNATIONAL issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 02/12/2024 via letter delivered via FedEx. The notice explained the issue, potential risk, and requested the following actions: Identify affected product in inventory, cease use, and quarantine pending return. If affected product is found, mark the applicable checkbox on the Acknowledgement Form and fax it to 1-855-419-8507, including Attn: Customer Service or using the e-mail address recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. If no product is inventory or on hand, mark the applicable checkbox on the Acknowledgement Form and return the form to Teleflex at the contact details provided. Distributors: Provide this field safety notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you. Immediately check your inventory for impacted product. Cease use and distribution of impacted product and immediately quarantine the affected product. You may then return all product in scope. Should you require further information or support concerning this issue, please contact Customer Service via email: recalls@teleflex.com, phone: 1-866-396-2111, or FAX: 1-855-419-8507 using the details provided below. Customer Service hours of operation are 8am 7pm EST.
Quantity in Commerce 1,160,470 devices
Distribution Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE, AR, AT, AU, BE, BH, BR, CA, CN, CO, CY, DE, EC, EE, ES, FR, GR, HK, HR, IT, KW, LB, LU, MX, MY, NL, NZ, PH, PL, QA, RU, SA, SE, SG, SI, TH, TW, and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
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