Recall StatusOpen, Classified
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.