Recall Z-1030-2015— Arrow International Inc
Class III · Terminated
Class III FDA medical device recall by Arrow International Inc, initiated 2015-01-09, terminated 2017-08-23. It names 2 FDA 510(k) clearances: K122545, K121941. Product: Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing. Reason: Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated..
- Recalling firm
- Arrow International Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-01-09
- Terminated
- 2017-08-23
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K122545 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET
- K121941 — ARROW PICC POWERED BY ARROW VPS STYLET
K-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 Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Reason for recall
Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.