Teleflex Medical Europe Ltd: Medical Device Recall in 2018 - (Recall #: Z-1369-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 15, 2018

Date Posted: April 18, 2018

Recall Number: Z-1369-2018

Event ID: 79579

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.

Status: Terminated

Product Quantity: 4220 units

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

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated