Home / Recalls / Teleflex Medical Europe Ltd / Z-1368-2018

Z-1368-2018 Class II Terminated

Recalled by Teleflex Medical Europe Ltd — Athlone

Recall Details

Product Type
Devices
Report Date
April 18, 2018
Initiation Date
March 15, 2018
Termination Date
October 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6340 units

Product Description

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.

Reason for Recall

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 Pattern

US Nationwide Distribution

Code Information

Batch Numbers: 13DE17 13EE22 13FE24 13FE26 13GE28 13GE29 13GE31 13KE47 13LE49 14AE03 14AE04 14FE25 14GE27 14HE32 14HE33 14HE35 14IE37 14IE38 14LE49 15AE05 15BE08 15CE13 15DE15 15DE16 15DE17 15DE18 15FE23 15FE25 15FE26 15GE27 15GE28 15GE29 15GE30 15HE32

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  • Z-2322-2021 Class II — RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, R (July 16, 2021)
  • Z-2321-2021 Class II — RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF n (July 16, 2021)
  • Z-2320-2021 Class II — RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers (July 16, 2021)
  • Z-2319-2021 Class II — RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers (July 16, 2021)
  • Z-2287-2018 Class II — Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage (June 12, 2018)
  • Z-1403-2018 Class II — Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, Q (March 27, 2018)
  • Z-1628-2018 Class II — Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, (March 19, 2018)
  • Z-1370-2018 Class II — Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (March 15, 2018)
  • Z-1369-2018 Class II — Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Co (March 15, 2018)
  • Z-1367-2018 Class II — Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) (March 15, 2018)