Teleflex Medical Europe Ltd: Medical Device Recall in 2018 - (Recall #: Z-1368-2018)

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:

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.

Product Classification:

Class II

Date Initiated: March 15, 2018

Date Posted: April 18, 2018

Recall Number: Z-1368-2018

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: 6340 units

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

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated