Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
FDA device recall Z-2825-2015 · posted 2015-09-30 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- 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.
- Action taken
- An urgent recall notification letter, dated August 27, 2015, was sent to direct consignees to inform them of the issue and provided instructions for removing the syringes from the kit and returning product along with the response form.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 73714
- Distribution
- Nationwide and internationally.
- Date initiated
- 2015-08-27
- Date posted
- 2015-09-30
- Date terminated
- 2018-06-18
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PICC (K042126) | Arrow Intl., Inc. | 2004-08-27 |
| MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT (K011761) | Arrow Intl., Inc. | 2001-10-31 |
| TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT (K002507) | Arrow Intl., Inc. | 2001-03-21 |
| TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION (K003006) | Arrow Intl., Inc. | 2000-10-27 |
| 19 GA PLASTIC REINFORCED EPIDURAL CATHETER (K001587) | Arrow Intl., Inc. | 2000-07-12 |