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U.S. Department of Health and Human Services

Class 2 Device Recall RochesterPean Hemostatic Forceps 61/4, Curved, Sterile.

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  Class 2 Device Recall RochesterPean Hemostatic Forceps 61/4, Curved, Sterile. see related information
Date Initiated by Firm October 28, 2016
Date Posted December 13, 2016
Recall Status1 Terminated 3 on April 17, 2017
Recall Number Z-0751-2017
Recall Event ID 75710
Product Classification Forceps, general & plastic surgery - Product Code GEN
Product Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile.

The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Code Information Catalog # ST7-138; lot# 352
Recalling Firm/
Manufacturer		 Integra York PA, Inc
589 Davies Dr
York PA 17402-8630
For Additional Information Contact Dr. Patricia W. Kihn
717-309-3966
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action The firm, Integra, mailed an "URGENT MEDICAL DEVICE RECALL NOTICE" dated October 26, 2016 to customers affected by the recall to notify them of the issue. The notice described the product, problem and actions to be taken. The customers were instructed to immediately review their inventory to determine if they had any of the recalled product on hand and to discontinue distributing the product; review your customer traceability records for shipment of the product and forward a copy of this Recall Notice to any of your customers that purchased the affected lots; complete and return the Acknowledgement Form that accompanied the notice (even if you do not have any product(s)) by email to: FCA3@integralife.com or fax to: 1-609-750-4220. Should you have any questions regarding these instructions, please contact Customer Service at 1-866-854-8300.
Quantity in Commerce 150 units
Distribution US Distribution in NC and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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