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 Recall Z-2161-2019 · Posted None
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeHDF
Date Initiated2019-07-01
Date Terminated2020-06-26
Product QuantityFrom Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each
Reason for Recall
Potential for sterile packaging to be compromised
Firm Action
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.
Root Cause
Employee error
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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