Class 2 Device Recall Hypodermic Single lumen Needle

• Date Initiated by Firm: October 08, 2019
• Create Date: December 16, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0690-2020
• Recall Event ID: 84054
• 510(K)Number: K141117
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
• Code Information: All
• Recalling Firm/ Manufacturer: Teleflex Medical; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer Reason for Recall: The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.
• FDA Determined Cause: Package design/selection
• Action: Urgent Medical Device Correction notification letters dated 10/8/19 were sent to customers. Customer Action: Our records indicate you have received product that is subject to this correction. Place a copy of this notice with the product to ensure all users are aware of the need to perform this inspection. Removing the kits from the shelf box and placing them into bags (e.g. backpacks) could increase the potential for caps to become loose and product should be visually inspected again at point of use. Our records indicate that you have received products that are subject to this action. We are notifying our customers to take the following actions: 1. Immediately discontinue use and quarantine any products with the catalog number and lot number listed above. 2. Inspect affected products within your control to identify if the safety cap covers the needle, per Figure 1 below, this product is acceptable for use. a) If, after inspection, you identify codes/lots as defective, please: " dispose of such product locally; and " inform us of the affected codes/lots by faxing such information to 1-855-419-8507 or email to recalls@teleflex.com in order for your account to be credited. 3. If you have defective product, please complete the enclosed Acknowledgement Form and fax to [distributor fax number]. 4. If you have no affected stock, please complete the enclosed Acknowledgment Form and fax it to [distributor fax number]. This will allow us to document your receipt of this letter.
• Quantity in Commerce: 526,000 total
• Distribution: US nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMI and Original Applicant = VIDACARE LLC