EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10
Reported: February 19, 2020 Initiated: January 15, 2020 #Z-1198-2020
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.
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? ▼
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10. 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-1198-2020.
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