—#174737

Product

STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.

FDA product code: HDF — Speculum, Vaginal, Metal
Device class: Class 1
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: Lot # 2019041790 Exp 3/31/2024 Lot # 2019030490 Exp 2/29/2024

Why it was recalled

Potential for sterile packaging to be compromised

Root cause (FDA determination)

Employee error

Action the firm took

1) Please identify all inventory that you have within your possession and segregate the recalled product. 2) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed. Please contact the number for any question (517) 546-5400 Ext.1122.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.

Timeline

Recall initiated: 2019-07-01
Terminated: 2020-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.