Medical Devices

Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg/mL - Particulates Found in Hospira supplied 1% Lidocaine HCl

Recall Class: Class I

Date Recall Initiated: September 30, 2013

Product: Custom Procedural Trays/Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL
Lot # 25-090-DK; See Lot Numbers for Custom Procedural Trays or Kits.

These affected products were manufactured from April 29, 2013 through August 20, 2013 and distributed from April 30, 2013 through September 20, 2013.

Use: Custom procedural trays or kits are a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products’ intended uses.

Recalling Firm:
Merit Medical Systems, Inc.
12701 N Kingston Avenue
Chester, Virginia 23836-2700

Manufacturer of the 1% Lidocaine HCl Injection:
Hospira, Inc.
275 N Field Drive
Lake Forest, Illinois 60045-2579

Reason for Recall: Hospira, Inc. is recalling one lot of 1% Lidocaine HCl Injection which is contained in the Custom Procedural Trays/Kits. These trays/kits were recalled due to one confirmed customer report of visible particulate, identified in the primary product container, in the form of dark red/black particles.

The particulate was identified as oxidized stainless steel. If oxidized stainless steel particulate is undetected, there is a potential to be injected and/or result in delay in therapy. These effects have the potential to result in serious life-threatening complications requiring medical intervention.

The presence of oxidized stainless steel particulate may potentially put a patient at risk from a strong magnetic field exposure such as with magnetic resonance imaging (MRI). If a metal particle in the lung becomes dislodged and pulled through tissue, possibly causing a collapsed lung (pneumothorax) or blood in the space between the chest wall (hemothorax), urgent and significant medical intervention may be required. The presence of oxidized stainless steel particulate could also result in blood clots in the lung and a stroke.

Public Contact: For questions, please call 1-804-416-1048 or 1-801-316-4822. For questions regarding this recall, call 1-804-416-1030.

FDA District: Baltimore District Office

FDA Comments:

On September 30, 2013, Merit Medical sent an “URGENT PRODUCT RECALL NOTICE” by FedEx to all its affected customers. The notice identified the affected product, description of the problem and recommended user actions to be taken.

Customers were given two options (Hospitals, Risk Managers, and Material Managers):

  1. Based upon immediate patient need, customers can keep the affected trays and dispose of the Lidocaine at the point of use.
    1. Merit will provide customers with warning labels, along with replacement Lidocaine for
      each affected tray based on their current inventory, or
    2. The label will instruct the user to dispose of the Lidocaine at the point of use and replace it with
      the new lot.
  2. They may return all affected trays remaining in inventory to Merit for credit or replacement.

Actions to be taken by the customer:

  • Immediately determine if any of the impacted trays/kits on the Customer Response Form are within your facility. If so, quarantine them and cease use.
  • Ensure that all appropriate personnel within your institution to which the affected Merit trays/kits were distributed are notified of this recall.

Complete and sign the Customer Response Form attached to the notice (determining if you are keeping or returning the affected product) and perform the following steps.

  1. Immediately fax a copy of the completed Customer Response Form to 1-801-316-4852.
  2. Mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit.
  3. Refer to the Customer Response Form for product return instructions.
  • If you choose to return the trays, please return the trays as instructed on the Customer Response Form.
  • If you choose to keep the trays, Merit will send you labels and Lidocaine upon receipt of the Customer Response Form. Please inform all appropriate personnel within your institution not to use the trays until they have been appropriately been labeled.
    • A copy of your previously submitted Customer Response Form and the instructions for labeling the trays and kits will be enclosed with your warning labels and replacement Lidocaine.
    • Please record in the box provided on the Customer Response Form the number of trays that you applied labels, sign the form, and fax it to 1-801-316-4852 or send an email to (jbraxton@merit.com).

If customers have any questions, please call 1-804-416-1048 or 1-801-316-4822. For questions regarding this recall, please call 1-804-416-1030.

Distributors were asked to:

Immediately determine if any of the impacted trays/kits on the Customer Response Form are within your facility. If so, quarantine them and notify your customer(s) of this urgent recall.

Ensure your customer(s) to which the affected Merit trays/kits were distributed are notified of this recall.

Determine, with your customer(s), the course of action from the following options:

  • You may return all affected trays remaining in your inventory to Merit for credit or replacement, or,
  • Merit can supply you with warning labels that must be placed on each individual tray or kit in your and your customer’s inventories. Instructions for labeling the trays and kits will be provided.
  • The label instructs the user to dispose of the Lidocaine at the point of use and replace it with the new lot.

See additional actions above to take.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links:

Page Last Updated: 06/03/2014
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