Events

Recall of Device Recall HemaSyst, Dual cannula Tip with Adapter 16 ga. x 4" (10.2 cm)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Haemacure Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61636
  • Event Risk Class
    Class 2
  • Event Number
    Z-1537-2012
  • Event Initiated Date
    2009-11-16
  • Event Date Posted
    2012-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108601
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Syringe, irrigating (non dental) - Product Code KYZ
  • Reason
    This product has been recalled due to the lot number being different on the box and pouch. the lot number on the box label was incorrectly printed as 11144 instead of 111144. the pouch label referenced the correct lot number, 111144.
  • Action
    Haemacure Corporation, Sarasota, FL initiated letters via e-mail on 11/16/2009 with delivery and read receipt confirmation to their two consignees. The letters identified the affected product and stated the reason for the recall. The letter also states that the firm will replace each order upon receipt of the mislabeled boxes at no charge to the customer. Customers were asked to return their unused devices. Questions should be directed to customer service at 1-877-872-4583.

Device

Device Recall HemaSyst, Dual cannula Tip with Adapter 16 ga. x 4" (10.2 cm)
  • Model / Serial
    Model H-1604, Lot Number 111144, expiration 10/2014
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Illinois and California.
  • Product Description
    HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul, MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota, FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***". || Sterile, single-use instrument for the application of two liquids.
  • Manufacturer
    Haemacure Corporation

Manufacturer

Haemacure Corporation
  • Manufacturer Address
    Haemacure Corporation, 600 Tallevast Rd, Sarasota FL 34243-3254
  • Source
    USFDA