Recall Z-0546-2014— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2013-10-09, terminated 2015-09-21. It names one FDA 510(k) clearance: K121403. Product: Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.. Reason: A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-09
- Terminated
- 2015-09-21
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Reason for recall
A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.