PlainRecalls
FDA Devices Moderate Class II Terminated

FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM

Reported: February 19, 2020 Initiated: January 15, 2020 #Z-1176-2020

Product Description

FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM

Reason for Recall

There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

Details

Recalling Firm
Arrow International Inc
Units Affected
343,105 total
Distribution
The products were distributed to 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.
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM. Recalled by Arrow International Inc. Units affected: 343,105 total.
Why was this product recalled?
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1176-2020.