Recall Z-1824-2015— CooperSurgical, Inc.

Name: FDA recall Z-1824-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-13

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2015-04-13, terminated 2016-02-05. It names one FDA 510(k) clearance: K841909. Product: McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures. Reason: Small sized specula were incorrectly packaged in printed bags for the medium sized speculum.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Terminated: 2016-02-05
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K841909 — VAGINAL SPECULUM - DISPOSABLEGalenica Enterprises, Inc.·cleared 1984-07-31

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

McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

Reason for recall

Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

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