The Recall Desk

FDA (Devices) recall action 79579

Teleflex Medical Europe Ltd recalled 4 products on 2018-04-18

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-04-18
Critical
0
Units
118,722

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2018-04-18

    Teleflex Medical Recalls Latex Rebreathing Bags Due to Missing Allergen Warning

    Teleflex Medical Europe Ltd is recalling 107,962 latex rebreathing bags because they lack the required warning that the product contains natural rubber latex, which may cause allergic reactions.

    Product
    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 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j)…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-04-18

    Teleflex Baker Jejunostomy Tubes Recalled for Missing Latex Warning

    Teleflex Medical Europe Ltd is recalling 200 Baker Jejunostomy Tubes because the packaging lacks a required warning that the product contains natural rubber latex.

    Product
    Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-04-18

    Teleflex Recalls Simplastic Suprapubic Puncture Instruments for Missing Latex Warning

    Teleflex Medical Europe Ltd is recalling Simplastic Suprapubic Puncture Instruments because the packaging lacks a required warning that the products contain natural rubber latex.

    Product
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-04-18

    Teleflex Medical Recalls Rectal Catheters Due to Missing Latex Warning

    Teleflex Medical Europe Ltd is recalling 6,340 rectal catheters because the packaging lacks a required warning that the product contains natural rubber latex.

    Product
    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.
    Category
    Distribution
    0 states