Food, drugs, devices › Teleflex Medical Europe Ltd
Device recall: Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respirat
Teleflex Medical Europe Ltd (Athlone) initiated this device recall on 27 Mar 2018; FDA lists 1 product record under event 79670, classified Class II.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 4 May 2021. Initiation: voluntary: firm initiated. Teleflex Medical Europe Ltd has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teleflex Medical Europe Ltd, Athlone, Ireland.
Reason for recall
"These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient."
Distribution
"US Nationwide in the states of AU, CA, NZ"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1403-2018 | Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system. | 103910 units | Class II | Terminated | 25 Apr 2018 |
Context
Other enforcement events for Teleflex Medical Europe Ltd
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Jul 2021 | RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 17006 | Device | Class II | 4 |
| 12 Jun 2018 | Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors | Device | Class II | 1 |
| 19 Mar 2018 | Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the applica | Device | Class II | 1 |
| 15 Mar 2018 | Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 15300001 | Device | Class II | 4 |
All 5 events for Teleflex Medical Europe Ltd
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide in the states of AU, CA, NZ"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 May 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.