Recall Z-2825-2015— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2015-08-27, terminated 2018-06-18. It names 5 FDA 510(k) clearances: K042126, K011761, K002507 and 2 more. Product: Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes. Reason: Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-27
- Terminated
- 2018-06-18
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
5 on FDA's record- K042126 — PICC
- K011761 — MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
- K002507 — TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
- K003006 — TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
- K001587 — 19 GA PLASTIC REINFORCED EPIDURAL CATHETER
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 Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Reason for recall
Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.
Data sourced from openFDA. This site is unofficial and independent of the FDA.