Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK Laparoscopic electric instruments are designed for use in minimally invasive procedures and/or open surgical procedures to facilitate coagulation, transaction, resection, mobilization and dissection of tissue.

FDA Recall Z-0560-2009 · Posted 2009-01-13

Recalling FirmSterilmed Inc
Recall StatusTerminated
Product CodeNUJ
Date Initiated2008-08-08
Date Terminated2011-04-26
Product Quantity273

Reason for Recall

SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

Firm Action

Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

Root Cause

Packaging process control

Distribution Pattern

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

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.

↑