VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditi
Hazard
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
What You Should Do
On May 17, 2018, Arrow International issued Urgent Medical Device Recall Notices and Response Forms to impacted customers via FedEx 2-day. Customers were advised to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. 2.To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Soon after, a customer service representative will contact customers with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3.If you have no affected stock, please complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the firm to document your receipt of the letter. Customers with questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
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Products
- Brand
- Arrow International Inc
- UPC
- Lot Numbers: 13F17A0287 & 13F17C0018
Units Affected
2070 units in total