—#203281

Product

Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K071538
Affected lot / code info: Batch/Lot number 33F23B0723

Why it was recalled

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return of the affected product.

Recalling firm

Firm: ARROW INTERNATIONAL Inc.
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2023-08-10
Posted by FDA: 2023-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.