Date Initiated by Firm |
November 16, 2009 |
Date Posted |
May 11, 2012 |
Recall Status1 |
Terminated 3 on May 14, 2012 |
Recall Number |
Z-1537-2012 |
Recall Event ID |
61636 |
510(K)Number |
K883338
|
Product Classification |
Syringe, irrigating (non dental) - Product Code KYZ
|
Product |
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.
|
Code Information |
Model H-1604, Lot Number 111144, expiration 10/2014 |
Recalling Firm/ Manufacturer |
Haemacure Corporation 600 Tallevast Rd Sarasota FL 34243-3254
|
For Additional Information Contact |
Dawn Benson 941-524-2546 Ext. 706
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
Labeling mix-ups |
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. |
Quantity in Commerce |
7 boxes |
Distribution |
Nationwide Distribution -- Illinois and California. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KYZ and Original Applicant = MICROMEDICS, INC.
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