Centurion Pelvic Exam Kits Recalled for Incomplete Sterile Seals
Centurion Medical Products is recalling specific lots of Pelvic Exam Kits because incomplete seals 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 involves a risk-of-harm product (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Pelvic Exam Kits (DYNDE1037) due to incomplete seals on the sterile package. The defect may compromise the sterility of the medical devices.
The recall affects lots 2019032090 and 2018091790. These products were distributed nationwide and in Ghana.
Healthcare providers and consumers should stop using the affected lots and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
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 (2)
- Lot Numbers: 2019032090
- 2018091790
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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