Recall Z-1537-2012 ยท KYZ Syringe, Irrigating (Non Dental)
Haemacure Corporation
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 p
| Date | May 11, 2012 (initiated Nov 16, 2009) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 7 boxes |
| Distribution | Nationwide Distribution -- Illinois and California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883338 | SURGICAL SEALANT APPLICATOR Micromedics, Inc., Aug 23, 1988 |