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Open, Classified

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

FDA Recall Z-1293-2024 · Posted 2024-03-14

Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2024-02-05
Product Quantity477,600

Reason for Recall

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

Firm 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]

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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