—#162429

Product

ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K151513
Affected lot / code info: Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)

Why it was recalled

Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

Root cause (FDA determination)

Process control

Action the firm took

Notification letters were sent to consignees with the following instructions: 1. If you have affected stock, quarantine so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.

Timeline

Recall initiated: 2017-12-15
Posted by FDA: 2018-03-14
Terminated: 2019-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162429. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.