FDAClass IIJune 6, 2018

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter recall: Sterility Concern

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle…

Why was MEDLINE O.R. Necessities(TM) Sterile* Needle Counter recalled?

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

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: 67016114502 67016124501 67016124502 67016124507 67017014501 67017024502 67017034501 67017034503 67017064502 67017074502 67017084502 67017084503 67017094501 67017094503 67017094505 67017104501 67017114501 67017114502

Product
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle…
Recalling firm
Medline Industries Inc
Quantity
80200 units
Distribution
Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
Recall date
June 6, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls