CLASS I ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Filter + Catheter Mount recalled by Teleflex
Teleflex is recalling Filter + Catheter Mount, distributed nationwide in the US. The recall was initiated on 29 Aug 2022 and the FDA has classified it as Class I.
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-0077-2023
- FDA event ID
- 90816
- Recalling firm
- Teleflex, Morrisville, NC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 29 Aug 2022
- FDA classified
- 14 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 29 Aug 2022 | Recall initiated by company | |
| 14 Oct 2022 | Classified by FDA | +46 days |
| 26 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incidents of device splitting or detaching during use
Product as listed by the FDA
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Where it was distributed
US nationwide distribution
Questions about this recall
Is Filter + Catheter Mount recalled?
Yes. Teleflex recalled Filter + Catheter Mount on 29 Aug 2022. The recall is Class I and its status is Ongoing. Recall number Z-0077-2023.
Why was it recalled?
Incidents of device splitting or detaching during use
Which lots are affected?
UDI: (01)04026704561544(17)250728(10)KMH20H0092, (01)04026704561544(17)250728(10)KMH20H0109, (01)04026704561544(17)251028(10)KMH20L0312, (01)04026704561544(17)251028(10)KMH20L0344, (01)04026704561544(17)251128(10)KMH20M0237, (01)04026704561544(17)251228(10)KMH21A0033, (01)04026704561544(17)260128(10)KMH21B0197, (01)04026704561544(17)260328(10)KMH21D0181, (01)04026704561544(17)260828(10)KMH21J0103, (01)04026704561544(17)260828(10)KMH21J0150, (01)04026704561544(17)261228(10)KMH22A0181, (01)04026704561544(17)261228(10)KMH22A0185.
Where was it sold?
US nationwide distribution
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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