Arrow International Recalls FlexTip Plus Epidural Catheterization Kits
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause 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 recall is classified as FDA Class II and involves a risk of dural puncture requiring a blood patch, which constitutes a significant injury report consistent with the Severe criteria.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Kits, Product Code AK-05501. The recall involves 343,105 units distributed to 38 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 LOR (loss of resistance) syringes included in the kits. These failures may result in dural puncture, with some cases requiring a blood patch. Specific lot numbers affected include 23F19A0301, 23F19F0108, 23F19F0481, 23F19H0079, 23F19J0305, 23F19L0094, 23F19C0303, 23F19F0297, 23F19G0039, 23F19H0145, 23F19J0484, 23F19L0209, 23F19D0266, 23F19F0388, 23F19G0263, 23F19H0386, 23F19K0171, and 23F19M0112.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected kits. Consumers should contact their healthcare provider if they have received this product.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
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