Recall Z-2489-2015— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2015-07-30, terminated 2018-02-26. It names 4 FDA 510(k) clearances: K130876, K121941, K103255 and 1 more. Product: Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days. Reason: saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-30
- Terminated
- 2018-02-26
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
4 on FDA's record- K130876 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET
- K121941 — ARROW PICC POWERED BY ARROW VPS STYLET
- K103255 — VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
- K073451 — PRESSURE INJECTABLE PICC
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 International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
Reason for recall
saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
Data sourced from openFDA. This site is unofficial and independent of the FDA.