Recall Z-1171-2020— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2020-01-15, terminated 2023-03-17. FDA's recall record names no specific 510(k) clearance for this event. Product: FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E. Reason: 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..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-15
- Terminated
- 2023-03-17
- Firm location
- Reading, PA, United States
Product description
FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.