Recall Z-2161-2019 ยท HDF Speculum, Vaginal, Metal
Centurion Medical Products Corporation
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.
| Date | Jul 1, 2019 |
| Status | Terminated |
| Reason | Potential for sterile packaging to be compromised |
| Root cause | Employee error |
| 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 |
| Quantity | From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.