Device recall

Z-1713-2020: Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10…

FDA device recall · Class III · CooperSurgical, Inc.

Key facts

Recall number (Z-number) Z-1713-2020
Recall event 85139
Product Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
Product code MFD
Recalling firm CooperSurgical, Inc.
Recall class Class III
Status Terminated
Termination date Aug 11, 2020
510(k) numbers K964848
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

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