Recall Z-1879-2018— CooperSurgical, Inc.

Name: FDA recall Z-1879-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-12

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2018-03-12, terminated 2019-05-08. It names one FDA 510(k) clearance: K061651. Product: Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151. Reason: Products have been packaged with an incorrect product size..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Terminated: 2019-05-08
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.·cleared 2006-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

Reason for recall

Products have been packaged with an incorrect product size.

Data sourced from openFDA. This site is unofficial and independent of the FDA.