Merit Medical Recalls Custom Procedural Trays Contaminated with Particulate Matter

Plain-English summary

Merit Medical Systems, Inc. is recalling 20,872 custom procedural trays and kits that contain 1% Lidocaine HCl Injection, USP, 10 mg/mL. The affected products were distributed nationwide to 37 states and the District of Columbia. The recall was initiated after one confirmed customer report identified visible particulate matter in the primary product container, described as dark red or black particles.

The presence of particulate matter in the injection poses a risk to patient safety. The source text states that the particulate matter may dislodge through the tissue and could possibly cause a pneumothorax or hemothorax. No specific illnesses or injuries have been reported in the source text, but the potential for serious respiratory complications is noted.

Healthcare facilities and consumers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. Affected products should be removed from use and returned to Merit Medical Systems or the distributor for credit or replacement. Users should contact their supplier or the manufacturer for specific instructions on handling the recalled items.

The recalled product

Product

Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the l

Manufacturer

Merit Medical Systems, Inc.

Category

Medical Device — Surgical Trays and Kits

Hazard

• contamination
• injury-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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