Centurion Recalls Sterile Graves Vaginal Speculums Due to Packaging Compromise
Centurion Medical Products is recalling sterile Graves vaginal speculums because the sterile packaging may be compromised, potentially exposing patients to infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where the sterile barrier may be compromised, creating a potential for infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Sterile Graves Vaginal Speculum Medium (Kit Code # GVS10MST). The recall is issued because there is a potential for the sterile packaging to be compromised. This product is used by medical professionals in a clinical setting to spread the walls of the vagina to facilitate examination.
The recall affects Lot # 2019041790 (Expiration 3/31/2024) and Lot # 2019030490 (Expiration 2/29/2024). A total of 2,825 units from the first lot and 3,500 units from the second lot were distributed. The products were distributed nationwide in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, and WI.
Healthcare facilities should stop using the affected speculums and contact Centurion Medical Products Corporation for further instructions. Patients who have had procedures using these specific lots should consult their healthcare provider if they have concerns regarding the integrity of the sterile packaging.
The recalled product
- 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.
- Manufacturer
- Centurion Medical Products Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 2019041790 Exp 3/31/2024 Lot # 2019030490 Exp 2/29/2024
Distribution
Part of a larger recall action
This product is one of 13 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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