The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0632-2017·Announced 2016-11-30

Merit Medical Recalls Manifold Kits Due to Compromised Sterile Barrier

Merit Medical Systems is recalling 40 Manifold Kits (Catalog No. K09-11867AP) because the sterile barrier is compromised, posing a risk of infection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the compromised sterile barrier presents a risk of harm (infection) without reported injuries or fatalities in the source text.

Plain-English summary

Merit Medical Systems, Inc. has announced a voluntary field action to recall 40 units of the Manifold Kit, Catalog Number K09-11867AP. The recall is being conducted because the sterile barrier of the product is compromised.

The affected product is identified by Lot Number H996495. The units were distributed nationwide to Virginia, Utah, and North Carolina, as well as to a foreign consignee in Japan. The source text notes that there were no Canadian or VA/government/military consignees.

This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected kits and contact Merit Medical Systems for further instructions.

The recalled product

Product
Manifold Kit. Catalog Number K09-11867AP
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
40

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 (1)

  • Lot Number: H996495

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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