Device recall

Z-1888-2008: M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum…

FDA device recall · Class II · Cooper Surgical, Inc.

Key facts

Recall number (Z-number) Z-1888-2008
Recall event 46377
Product M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.
Product code HDB
Recalling firm Cooper Surgical, Inc.
Recall class Class II
Status Terminated
Termination date May 23, 2012
510(k) numbers K011532
FEI number 1216677

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)