Home / Recalls / Teleflex Medical Europe Ltd / Z-1369-2018

Z-1369-2018 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
4220 units

Product Description

Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.

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

Product Code Equivalent Code (a) 650704100 551310 Batch Numbers: 13HE35 14KE45 (b) 650704120 551312 Batch Numbers: 13EE20 13HE35 13JE43 14AE02 14BE07 14EE21 14GE29 14IE39 15AE03 15HE32 (c) 650704160 551316 Batch Numbers: 13GE31 13HE35 13JE41 13JE42 13JE43 13KE48 14AE03 14BE07 14CE11 14DE17 14DE18 14EE21 14EG21 14GE28 14HE33 14HE35 14IE39 14KE45 15AE03 15EE20 15EE22 15GE28 15JE43 15JE44 13EG28 13HG23

Other recalls by Teleflex Medical Europe Ltd

  • 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-1368-2018 Class II — Rectal Catheters; Product Code Equivalent Code 580114 580114 Pro (March 15, 2018)
  • Z-1367-2018 Class II — Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) (March 15, 2018)