The Recall Desk

FDA (Devices) recall action 69500

CooperSurgical, Inc. recalled 2 products on 2014-11-19

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-11-19
Critical
0
Units
23

Why these products were recalled

Incorrect expiration date printed on the MILEX PESSARY KIT packaging

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.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2014-11-19

    CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date

    CooperSurgical is recalling 17 MILEX Pessary Kits because the packaging displays an incorrect expiration date.

    Product
    CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary…
    Category
    Distribution
    13 states
  • LowFDA (Devices)··2014-11-19

    CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date

    CooperSurgical is recalling 6 units of MILEX Pessary Kits due to incorrect expiration dates printed on the packaging.

    Product
    CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary…
    Category
    Distribution
    13 states