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Terminated

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.

FDA Recall Z-0100-2015 · Posted 2014-10-21

Recalling FirmGyrus Medical, Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2014-08-27
Date Terminated2015-09-15
Product Quantity5520 US, 40 OUS

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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