FDA Device

REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475

Hazard

There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

What You Should Do

Remedy

On October 4, 2019, a "Urgent: Medical Device Recall" Letter was sent to all affected customers via US Mail. In addition to providing customers information on the recalled products, the letter asked customers to do the following: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) Return affected product using the return label provided with this letter. Contact Stericycle at 1-866-367-4703 (Monday - Friday, 8:00 am-5:00 pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned. You will only receive credit for product that you return. NOTE: Credits for product purchased through distributor will be credited by the distributor. 4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-866-367-4703 (M-F, 8am-5pm ET) to obtain a response form. 5) Replacement product is available. Please contact customer service using the information provided below. - Global Complaint Management - 1-844-654-7780 or ProductComplaintsPP@icumed.com, To report adverse events or product complaints - C

Products

REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
Brand
ICU Medical, Inc.
UPC
Lot number 4173657 *Product not distributed within the US

Units Affected

1175 units