ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
ARROW International is recalling 1,160,470 QuickFlash radial artery catheterization devices due to a defective guidewire handle that can cause arterial vasospasm and vessel injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity level of Severe (4) per regulatory guidelines. Although the defect can cause serious vascular complications (arterial vasospasm, vessel injury), no actual illnesses or injuries are reported in the source.
Plain-English summary
ARROW International is recalling its QuickFlash Radial Artery Catheterization devices due to a defective component affecting the guidewire handle and chamber. The defect involves excessive resistance during use, which can result in arterial vasospasm and vessel injury, particularly when multiple arterial punctures are required during catheter placement attempts.
The recall affects 1,160,470 devices distributed worldwide, including throughout the United States and 37 other countries. Affected devices are identified by multiple part numbers and specific lot numbers documented by the FDA.
Healthcare providers and facilities with these devices should verify their inventory using the part numbers and lot numbers specified in the FDA recall notice. Additional information is available from ARROW International and the FDA.
The recalled product
- 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)…
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Affected units
- 1,160,470
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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