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 recall is classified as FDA Class II and involves a risk of significant injury (dural puncture requiring a blood patch), which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM. The recall affects specific lots: 23F19E0116, 23F19G0501, and 23F19K0188.
The recall was initiated because there is a potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures can result in dural puncture, with some instances requiring a blood patch.
The products were distributed to healthcare facilities in the following US states: 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. Healthcare providers should check their inventory for the affected product codes and lot numbers and stop using the recalled kits.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM
- 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: 23F19E0116 23F19G0501 23F19K0188
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