FDA recall Z-2699-2017

Product

Arrow Glide Thru Peel-Away Sheath/Dilator Introducer

Reason for recall

Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.

Distribution

Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok

Key facts

Status

Terminated

Initiation date

2017-06-12

Report date

2017-07-19

Termination date

2018-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2699-2017