Recall Z-2699-2017 ยท DYB Introducer, Catheter
Arrow International Inc
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
| Date | Jun 27, 2017 (initiated Jun 12, 2017) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER Arrow International (Subsidiary of Teleflex Inc.), Jan 4, 2013 |