Z-0690-2018Class II
ARROW PICC powered by ARROW VPS Stylet
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-10-17 / Terminated
Arrow International Inc began a recall of ARROW PICC powered by ARROW VPS Stylet on . FDA classified it as Class II and gives the reason as "The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0690-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- ARROW PICC powered by ARROW VPS Stylet
- Product code
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Reason for recall
- The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
- FDA root cause
- Mixed-up of materials/components
- Action
- On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990.
- Quantity in commerce
- 601 eaches
- Distribution
- AZ, CA, GA, MA, MO, NY, VA
- Product codes and lots
- CDC 34041 VPS Lot# 23F17A0037 23F17B0035
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0690-2018 | Class II | Terminated | Voluntary: Firm initiated |
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