FDAClass IIDecember 21, 2016

Rochester-Pean Hemostatic Forceps 61/4 recall: Sterility Concern

Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments…

Why was Rochester-Pean Hemostatic Forceps 61/4 recalled?

The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.

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?

Catalog # ST7-138; lot# 352

Product
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments…
Recalling firm
Integra York PA, Inc
Quantity
150 units
Distribution
US Distribution in NC and TX.
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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