Recall Z-1267-2024 ยท DQX Wire, Guide, Catheter
ARROW INTERNATIONAL Inc.
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
| Date | Mar 21, 2024 (initiated Feb 12, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 ( |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160018 | Arrow Quickflash Arterial Catheterization Device Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Jun 13, 2016 |