Centurion Medical Recalls Circumcision Kits Due to Sterile Packaging Concerns
Centurion Medical Products Corporation is recalling 168 Circumcision Tray kits because sterile packaging may be compromised. The kits are used for newborn circumcision procedures.
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 product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed illness.
Plain-English summary
Centurion Medical Products Corporation is recalling 168 units of the Circumcision Tray (Kit Code: CIT2650H) due to a potential for sterile packaging to be compromised. The product is a medical kit used for performing circumcision procedures on newborns.
The affected units are identified by Lot # 2019051390 and have an expiration date of 8/31/2021. The recall covers distribution 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 providers and consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a return.
The recalled product
- Product
- CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 168
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 # 2019051390 Exp: 8/31/2021
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.
See all 13 products in this recall →Related recalls
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