FDAClass IIFebruary 12, 2020

Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY recall: Sterility Concern

Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790

Why was Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY recalled?

Incomplete seals on the sterile package may compromise the sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 2019032090, 2018091790,

Product
Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
Recalling firm
Centurion Medical Products Corporation
Quantity
N/A
Distribution
Nationwide Foreign: GHANA
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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