Z-1628-2016Class II

GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC

Name: Z-1628-2016 GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC
Creator: Baxter Healthcare Corp.
Published: 2016-04-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2016-04-21 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device... on 2016-04-21. FDA classified it as Class II and gives the reason as "Instructions for use booklet may puncture the outer Tyvek lid". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1628-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-21
Posted: 2016-05-10
Terminated: 2016-11-22
Recalling firm: Baxter Healthcare Corporation
Product: GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-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.
Product code: DPW Flowmeter, Blood, Cardiovascular
Reason for recall: Instructions for use booklet may puncture the outer Tyvek lid.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 630 units
Distribution: Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
Product codes and lots: SP15H05-1067842 thru SP15KI9-1099303

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1628-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1627-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09
Z-1628-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09
Z-1629-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09
Z-1630-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09
Z-1631-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09

Product code DPW

K132727Class IIGem Flow Coupler Device and SystemSynovis Life Technologies, Inc. / cleared 2013-10-22

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)