Recall Z-1627-2016
Baxter Healthcare Corp. · initiated April 21, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
Codes / lots: SP15H05-1067843 thru SP15K05 -1094463
Reason for recall
Instructions for use booklet may puncture the outer Tyvek lid.
FDA-determined cause: Package design/selection
Action taken
Baxter sent an Urgent Product Recall letter dated April 21, 2016 to customer. The letter identified the affected product, problem and actions to be taken. The letters requested that direct consignees contact Synovis MCA to arrange for return and credit. Companies that further distributed the product were asked to notify other facilities or departments. For questions contact Synovis MCA at 800-510-3318 or 205-941-0111.
Details
- Recall number
- Z-1627-2016
- Initiated
- April 21, 2016
- Terminated
- November 22, 2016
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 315 units
- Distribution
- Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1628-2016 Class II | GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC.…Instructions for use booklet may puncture the outer Tyvek lid. | 04/21/2016Terminated |
| Z-1629-2016 Class II | GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC…Instructions for use booklet may puncture the outer Tyvek lid. | 04/21/2016Terminated |
| Z-1630-2016 Class II | GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC…Instructions for use booklet may puncture the outer Tyvek lid. | 04/21/2016Terminated |
| Z-1631-2016 Class II | GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC…Instructions for use booklet may puncture the outer Tyvek lid. | 04/21/2016Terminated |