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U.S. Department of Health and Human Services

Class 2 Device Recall HemaSyst, Dual cannula Tip with Adapter 16 ga. x 4" (10.2 cm)

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 Class 2 Recall
HemaSyst, Dual cannula Tip with Adapter 16 ga. x 4" (10.2 cm)
see related information
Date Posted May 11, 2012
Recall Status1 Terminated on May 14, 2012
Recall Number Z-1537-2012
Recall Event ID 61636
Premarket Notification
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, Florida 34243-3254
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KYZ and Original Applicant = MICROMEDICS, INC.
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