Arrow International Recalls TheraCath Epidural Catheterization Kits
Arrow International is recalling TheraCath Epidural Catheterization Kits because the included loss of resistance syringes may fail, potentially causing dural puncture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: 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' rubric criteria.
Plain-English summary
Arrow International Inc is recalling 343,105 units of TheraCath Epidural Catheterization Kits, Product Code ASK-05001-SLR1. The recall involves specific lots: 23F18M0499, 23F19F0164, 23F19H0109, 23F19L0471, 23F19C0409, 23F19G0535, and 23F19K0082. The products were distributed to healthcare facilities in 36 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 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, a condition where the dura mater is accidentally punctured during the procedure. In some cases, patients may require a blood patch to treat the puncture.
Healthcare providers should stop using the affected kits and contact Arrow International Inc for further instructions on the recall process. Patients who have received these kits should consult their healthcare provider if they experience symptoms associated with dural puncture.
The recalled product
- Product
- TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
- 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
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
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
Similar recalls
- HighArrow TheraCath Epidural Catheters Recalled for Unsealed Packaging
FDA (Devices) · 2018-06-06
- ModerateArrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date
FDA (Devices) · 2020-02-26
- ModerateArrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date
FDA (Devices) · 2020-08-19
- HighArrow Epidural Catheter Kits Recalled Due to Adhesive Manufacturing Defect
FDA (Devices) · 2026-04-29
- LowArrow FlexTip Plus Epidural Catheterization Kit Recalled for Incorrect Expiration Date
FDA (Devices) · 2020-02-26
- SevereArrow epidural catheter kits contain drugs from a recalled supplier
FDA (Devices) · 2026-06-24