GEM(TM) recall
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…
Why was GEM(TM) recalled?
Instructions for use booklet may puncture the outer Tyvek lid.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SP15H05-1067843 thru SP15K05 -1094463
- 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…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 315 units
- Distribution
- Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
- Recall date
- May 18, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)