Recall Z-0689-2020

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 taken

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.