Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
FDA Recall Z-2699-2017 · Posted 2017-06-27
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-06-12
Date Terminated2018-09-06
Product Quantity9,037 units in the U.S. and 4,505 Internationally
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.
Firm Action
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
Distribution Pattern
Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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