Z-1537-2012

HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch...

Name: Z-1537-2012 HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch...
Creator: Haemacure Corporation
Published: 2009-11-16
License: https://open.fda.gov/license/

Haemacure Corp. / initiated 2009-11-16 / Terminated / root cause: labeling and UDI

FDA source

Haemacure Corporation began a recall of 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... on 2009-11-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1537-2012
Status: Terminated
Initiated: 2009-11-16
Posted: 2012-05-11
Terminated: 2012-05-14
Recalling firm: Haemacure Corp.
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.
Product code: KYZ Syringe, Irrigating (Non Dental)
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 7 boxes
Distribution: Nationwide Distribution -- Illinois and California.
Product codes and lots: Model H-1604, Lot Number 111144, expiration 10/2014

Product code KYZ

K883338Class ISurgical Sealant ApplicatorMicromedics, Inc. / cleared 1988-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)