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Lap Instruments/Graspers/Forceps - HOT recallZ-0560-2009 · Sterilmed Inc · initiated Aug 8, 2008

Terminated All recalls posted in January 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sterilmed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-0560-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 8, 2008
Posted by the FDA
Jan 13, 2009
Recalling firm
Sterilmed Inc
Quantity
273
Product code
NUJ
FDA submissions
K012598, K050136
Distribution
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

Product description

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.

Code information (models, lots, serial numbers)

n/a

Other devices under the same FDA submission

2 devices cleared under K012598, K050136 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 49510).

Sources and updates

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