Recall Z-1239-2015— CooperSurgical, Inc.

Name: FDA recall Z-1239-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-09

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2015-02-09, terminated 2016-01-15. It names one FDA 510(k) clearance: K904026. Product: CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02. Reason: Incorrect size printed on the Milex Pessary Kit packaging label.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-09
Terminated: 2016-01-15
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K904026 — INFLAT-O-BALLMilex Products, Inc.·cleared 1990-10-10

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

CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02

Reason for recall

Incorrect size printed on the Milex Pessary Kit packaging label

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