The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0980-2014·Announced 2014-02-26

Merit Medical Recalls Custom Procedural Trays Contaminated with Particulate Matter

Merit Medical Systems is recalling custom procedural trays containing 1% Lidocaine HCl injection due to visible particulate matter found in the product container.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The…"

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…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Surgical Trays and Kits
Hazard

Is your product affected?

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

Lot numbers (20)

  • Tray/Kit SPPT-5F-10/D
  • Lot # T491273
  • Exp. 31-Dec-2014
  • SPPT-5F-10/D
  • Lot # T512967
  • Exp.31-Dec-2014
  • K12T-04453
  • Lot # T472220
  • K12T-04454
  • Lot # T487452
  • K12T-04455B
  • Lot # T479169
  • Lot # T502497
  • Exp. 31-Jul-2014
  • K12T04455B
  • Lot #T479169
  • K12T-03650C
  • Lot #T483624
  • Exp. 31-Oct-2014
  • K12T-04082B

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

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