FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- Recall number
- Z-2699-2017
- Recalling firm
- Arrow International Inc
- Product
- Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- Status
- Terminated
- Initiated
- 2017-06-12
- Posted
- 2017-06-27
- Terminated
- 2018-09-06
- Reason
- 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.
- Root cause
- Device Design
- 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.
- Quantity
- 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
- Lot, serial or model codes
- Device Listing # D184260 Material # PL-01055
- 510(k) numbers
- ["K122854"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28