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U.S. Department of Health and Human Services

Class 2 Device Recall GYRUS ACMI, Sterile EO

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  Class 2 Device Recall GYRUS ACMI, Sterile EO see related information
Date Initiated by Firm August 27, 2014
Date Posted October 21, 2014
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-0100-2015
Recall Event ID 69226
510(K)Number K031078  K031081  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm
REF 3345PK - PKS MOLly Forceps 5mm/45cm
REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm
REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm
REF 3844- Everest BiCOAG LP Scissors 5mm/45cm
REF 910010PK- PKS MOLly Forceps 5mm/45cm

Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Code Information All product manufactured before July 28, 2014.
Recalling Firm/
Manufacturer		 Gyrus Medical, Inc
6655 Wedgwood Rd N Ste 160
Osseo MN 55311-3613
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer Reason
for Recall		 Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
FDA Determined
Cause 2		 Packaging process control
Action Olympus sent a Medical Device Recall letter dated August 26, 2014, via FEDEX to all affected consignees. The letter described the issue and the product involved in the recall. It also described the action that the consignee needs to take. Consignees were instructed to cease further use of the device, quarantine it and return it to the manufacturer.Consigness were instructed to complete and return by fax (484-896-7128) the questionnaire enclosed. If the product was further distributed consignees should notify their customers of the product recall. For additional information they can call 484-896-5688. For questions regarding this recall call 484-896-5688.
Quantity in Commerce 5520 US, 40 OUS
Distribution Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GYRUS MEDICAL, INC.
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