Recall Z-1965-2013— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2013-07-31, terminated 2015-04-28. It names one FDA 510(k) clearance: K862056. Product: Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.. Reason: Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-31
- Terminated
- 2015-04-28
- 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
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Reason for recall
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
Data sourced from openFDA. This site is unofficial and independent of the FDA.