—#156756

Product

Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K112896
Affected lot / code info: Device Listing # D149129 Material # ASK-45552-RWJ4 PR-45552-HPHNL

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 #156756. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.