Centurion OB Instrument Tray Recalled for Detachable Needle Guide Component
Medline is recalling Centurion OB Instrument Trays because the Trumpet Needle Guide ring can detach when excessive pressure is applied. This could affect instrument functionality during medical 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: FDA Class II medical device recall for a functional defect where a critical component can detach during use. No injuries or illnesses have been reported, but the risk of harm during obstetric procedures warrants a High severity classification.
Plain-English summary
Medline Industries, LP is recalling the Centurion OB INSTRUMENT TRAY (Reference Number MN3925) due to a defect in the Trumpet Needle Guide ring. The ring can detach when excessive pressure is applied during use, potentially compromising instrument functionality during obstetric procedures.
Affected units include Lot Numbers 23JBX257 and 23KMG455, which were distributed nationwide in the United States. The product is used as a medical procedure convenience tray in obstetric settings.
Healthcare facilities and providers with affected units should immediately discontinue use and contact Medline Industries for return or replacement instructions. Affected devices should be quarantined and not used on patients.
The recalled product
- Product
- Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 30
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 (4)
- UDI/DI 40653160122945 (case)
- 10653160122944 (unit)
- Lot Numbers: 23JBX257
- 23KMG455
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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