CLASS II Device recall · Reported 30 Nov 2016 · FDA Enforcement Report
Manifold Kit recalled by Merit Medical Systems
Merit Medical Systems is recalling Manifold Kit, distributed nationwide in the US. The recall was initiated on 23 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0632-2017
- FDA event ID
- 75367
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2016
- FDA classified
- 19 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Sep 2016 | Recall initiated by company | |
| 19 Nov 2016 | Classified by FDA | +57 days |
| 30 Nov 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Manifold Kit. Catalog Number K09-11867AP
Where it was distributed
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Questions about this recall
Is Manifold Kit recalled?
Yes. Merit Medical Systems recalled Manifold Kit on 23 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0632-2017.
Why was it recalled?
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Which lots are affected?
Lot Number: H996495
Where was it sold?
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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