Centurion Circumcision Tray Kits Recalled for Incomplete Sterile Seals
Centurion Medical Products is recalling specific Circumcision Tray Kits because incomplete seals on the sterile packaging may compromise sterility.
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 is classified as FDA Class II. The hazard involves compromised sterility of a surgical device, which poses a risk of infection (risk-of-harm), but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Circumcision Tray Kits and Universal Circumcision Trays. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the medical devices.
The affected products include various models such as the DYNDF1078C, DYNDF1082, DYNDF1093C, DYNDF1109, and DYNDF1128. Specific lot numbers are listed in the official recall notice. These products were distributed nationwide and to Ghana.
Healthcare providers and consumers should stop using these specific lots and contact Centurion Medical Products Corporation for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
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)
- CIRCUMCISION 2019020690 DYNDF1128 CIRCUMCISION TRAY 2018121490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 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 54 products in this recall →Related recalls
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