FDA Recall Open, Classified

EasyPoint Needle, 25G x 5/8", REF: 82091

Recall: Z-1293-2024 · Initiated February 5, 2024

Recall

Recall Number
Z-1293-2024
Event Number
93981
Firm
Retractable Technologies, Inc.
FEI Number
1000306068
Product Code
FMI
Status
Open, Classified
Root Cause
Process control
Initiated
February 5, 2024
Posted
March 14, 2024
Address
511 Lobo Ln, Little Elm, TX, 75068-5295

Description

EasyPoint Needle, 25G x 5/8", REF: 82091

Reason

The needle cannula of a retractable needle may detach from the needle holder in the patient.

Action

On 2/5/24, recall notices were sent to customers and distributors who were asked to do the following: 1) Segregate, quarantine, and discontinue use and distribution of affected devices. 2) Inform all personnel who have received or are receiving affected devices that they should not use affected devices. 3) If affected product was further distributed, notify these additional customers immediately. When notifying customers include a copy of the recall notice, label images, and the response form. 4) Complete and return the response form to [email protected] Customers with additional questions can email the firm at [email protected]

Distribution

US Nationwide distribution including in the states of NY, FL, IL, MA, UT, NJ, AZ, MO, WA, NC, CA, TX, NV, IN, PA, VA, IA, GA, TN, MI, OH, OK, CO, OR, SC, MN, CT.

Quantity

477,600