5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

On 05/19/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx 2-day to customers informing them that the Recalling Firm has confirmed through customer complaint that a number of catheter convenience kits labeled as having 70cm guidewires may actually contain 50cm guidewires. The Recalling Firm is providing customers with a quick way of identifying if their kit contains the correct or incorrect size guidewire by determining the number of loops of the wire. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers listed. Determine if the product has the correct product based on the number of loops of the guidewire while the product is still in the packaging material. Product may be discarded when clinically necessary and replacement requested. 2. Share this recall notification with all users within or outside their facility network to which they may have further distributed the affected products to ensure these additional users are also aware of this advisory notice. 3. Complete the attached Customer Response Form and return to the Recalling Firm contact noted on the form whether or not they have any of the impacted material so that Recalling Firm may acknowledge receipt of this notification per FDA requirements and subsequently process the product replacement, if necessary. For further assistance or for questions - contact: North American Regional Complaint Center 1-84BD-LIFE (1-844-823-5433) Say Recall when prompted MonFri 8:00am and 5:00pm CT