Z-1198-2020 Class II Terminated
FDA device recall Z-1198-2020 was initiated by Arrow International Inc on January 15, 2020 and is designated Class II. 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. The recall status is terminated (terminated March 17, 2023). Affected quantity: 343,105 total.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- January 15, 2020
- Termination Date
- March 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 343,105 total
Product Description
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10
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.
Distribution Pattern
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.
Code Information
Lots: 71F19B1457 71F19D1662 71F19G0145 71F19H2708 71F19K2670 71F19C1527 71F19E1145 71F19G2429 71F19J1367 71F19C2577 71F19E2862 71F19H1833 71F19K0948