HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***
FDA device recall Z-1537-2012 · posted 2012-05-11 · Terminated
Recall details
- Recalling firm
- Haemacure Corporation
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KYZ
- Quantity affected
- 7 boxes
- Distribution
- Nationwide Distribution -- Illinois and California.
- Date initiated
- 2009-11-16
- Date posted
- 2012-05-11
- Date terminated
- 2012-05-14
- Location
- Sarasota, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL SEALANT APPLICATOR (K883338) | Micromedics, Inc. | 1988-08-23 |