Recalls / —
—#156760
Product
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- FDA product code
- DYB — Introducer, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K122854
- Affected lot / code info
- Device Listing # D184260 Material # PL-01055
Why it was recalled
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 (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Timeline
- Recall initiated
- 2017-06-12
- Posted by FDA
- 2017-06-27
- Terminated
- 2018-09-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #156760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.