Arrow Glide Thru Peel-Away Sheath/Dilator Introducer

FDA device recall Z-2699-2017 · posted 2017-06-27 · Terminated

Recall details

Recalling firm

Arrow International Inc

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.

Action taken

Teleflex/Arrow International mailed an Urgent Medical Device Recall Notification Letter to affected customers on 06/12/2017 to inform them of the issue. Arrow requested that customers examine their inventory immediately for the affected lots and discontinue use and quarantine any products with the associated product codes identified in the notice and complete the Recall Acknowledgement Form and fax back to the number included in the notice.

Root cause

Device Design

Status

Terminated

Product code

DYB

Quantity affected

9,037 units in the U.S. and 4,505 Internationally

Distribution

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

Date initiated

2017-06-12

Date posted

2017-06-27

Date terminated

2018-09-06

Location

Reading, PA

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