Recall Z-0066-2015— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2014-08-06, terminated 2016-10-14. It names 5 FDA 510(k) clearances: K073451, K011761, K862056 and 2 more. Product: Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.. Reason: The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-06
- Terminated
- 2016-10-14
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K073451 — PRESSURE INJECTABLE PICC
- K011761 — MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
- K862056 — [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
- K810675 — ARROW RADIAL ARTERY CATHETERIZATION SET
- K780532 — PERCUTANEOUS SHEATH INTRODUCER KIT
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) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Reason for recall
The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.