PlainRecalls
FDA Devices Moderate Class II Terminated

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.

Reported: August 22, 2018 Initiated: July 10, 2018 #Z-2818-2018

Product Description

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.

Reason for Recall

The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

Details

Recalling Firm
Arrow International Inc
Units Affected
7024 units
Distribution
Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom.
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.. Recalled by Arrow International Inc. Units affected: 7024 units.
Why was this product recalled?
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 22, 2018. Severity: Moderate. Recall number: Z-2818-2018.