Recalls / —
—#161613
Product
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
- FDA product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K071538
- Affected lot / code info
- Lot number: 23F17D0182
Why it was recalled
These finished good kits may contain the incorrect Springwire Guide (SWG).
Root cause (FDA determination)
Process control
Action the firm took
On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- Distribution US Nationwide
Timeline
- Recall initiated
- 2017-10-17
- Posted by FDA
- 2018-02-20
- Terminated
- 2020-04-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161613. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.