Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections. |
|---|---|
| Recall Number | Z-1823-2012 |
| Classification | Class II |
| Code Info | Lot number RF2033361 |
| Product Distributed Qty | 1,085 |
| Reason For Recall | Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover. |
Event Detail
| Event Id | 62125 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Arrow International Inc |
| City | Reading |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI. |
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