Reported Oct 28, 2020 · Terminated
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN:…
Medtronic Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular · 35-37A Cherry Hill Drive · Danvers, MA · 01923-2565
Is this the product you have?
- Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric
- Single Lumen Product number007161
- GTIN00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality
- Lot codes and dates
- Lot Numbers
GFCR2342GFCR2583GFCX2785GFCY3003GFDN0248GFDQ2501GFDR2902GFDS2211GFDT2171GFDT2201GFDU2169GFDV2178GFDW2400GFDX2710GFDY1133GFDY1134
- Lot Numbers
- Amount recalled
- 505 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Subsequent failure of catheters in the field and failed quality testing
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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