Devices

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

Model / Serial
Model H-1604, Lot Number 111144, expiration 10/2014
Product Classification
General Hospital and Personal Use Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution -- Illinois and California.
Product Description
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.
Manufacturer
Haemacure Corporation
1 Event
- Recall of Device Recall HemaSyst, Dual cannula Tip with Adapter 16 ga. x 4" (10.2 cm)

Manufacturer

Haemacure Corporation

Manufacturer Address
Haemacure Corporation, 600 Tallevast Rd, Sarasota FL 34243-3254
Source
USFDA

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