FDA Recall Terminated

MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Recall: Z-1933-2018 · Initiated April 24, 2018

Recall

Recall Number
Z-1933-2018
Event Number
80017
Firm
Medline Industries Inc
FEI Number
1417592
Product Code
GAB
Status
Terminated
Root Cause
Package design/selection
Initiated
April 24, 2018
Terminated
August 4, 2020
Address
Three Lakes Drive, Northfield, IL, 60093

Description

MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Reason

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Action

Medline sent an Urgent Recall letter dated April 24, 2018. The letter identified the affected product, problem and actions to be taken. Customer were instructed to check inventory, quarantine all affected product and return completed enclosed response form. Those consignees who further distributed the product were directed to notify their customers. For question contact 866-359-1704.

Distribution

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

Quantity

220608 units