Arrow International Recalls FlexTip Plus Epidural Catheterization Kits
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect results in dural puncture with some cases requiring a blood patch, which constitutes a significant injury report under the rubric for a score of 4.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Kits, Product Code AK-05500. The recall involves 343,105 units from lots 13F19G0085 and 13F19H0381. These products were distributed to 37 US states, including AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
The recall is due to the potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures may result in dural puncture, with some instances requiring a blood patch. The FDA has classified this as a Class II recall.
Healthcare providers and facilities should stop using the affected kits and contact Arrow International for further instructions on returns or replacements.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
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 (1)
- Lots: 13F19G0085 13F19H0381
Distribution
Part of a larger recall action
This product is one of 49 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 49 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · dural puncture
See all →- SevereArrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Kits
FDA (Devices) · 2020-02-19
- HighArrow International Recalls Epidural Catheterization Kits Due to Syringe Failures
FDA (Devices) · 2020-02-19
- SevereArrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
FDA (Devices) · 2020-02-19
- HighArrow International Recalls FlexTip Plus Epidural Catheterization Kits
FDA (Devices) · 2020-02-19
- SevereArrow International Recalls FlexTip Plus Epidural Catheterization Kits
FDA (Devices) · 2020-02-19