Athlone, Ireland
Teleflex Medical Europe Ltd recalls
5 recalls recorded since 2018, most recently on 16 July 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 July 2021
- Terminated
- 24 July 2026
- Reason
- The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2319-2021, Z-2322-2021, Z-2321-2021, Z-2320-2021
- RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
- RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 1120820
- RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090
- RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Terminated Class II Medical devices
- Recall started
- 12 June 2018
- Terminated
- 2 April 2021
- Reason
- The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada, India
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2287-2018
- Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
Terminated Class II Medical devices
- Recall started
- 27 March 2018
- Terminated
- 4 May 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 19 March 2018
- Terminated
- 27 August 2019
- Reason
- Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1628-2018
- Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
Terminated Class II Medical devices
- Recall started
- 15 March 2018
- Terminated
- 5 October 2020
- Reason
- These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1369-2018, Z-1368-2018, Z-1367-2018, Z-1370-2018
- Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Punct
- Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
- Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107
- Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.