Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1239-2015 · Posted 2015-03-03

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHHW
Date Initiated2015-02-09
Date Terminated2016-01-15
Product Quantity95 units

Reason for Recall

Incorrect size printed on the Milex Pessary Kit packaging label

Firm Action

CooperSurgical sent an Recall Letter dated February 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter asked customers to contact CooperSurgical Product Surveillance Department if they had any questions. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Questions contact CooperSurgical 203.601.5200.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904026INFLAT-O-BALLMilex Products, Inc. · 1990-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑