Reported Oct 28, 2020 · Terminated
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number:…
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, 6F, Recess Balloon, Closed end, 50 cm, Pediatric
- Single Lumen Product number008764
- GTIN00613994760289 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
GFCP2154GFCR2591GFCR2592GFCS2156GFCU2199GFCV2587GFCW1652GFCW2431GFCX2712GFCY2997GFDN0246GFDN3553GFDN3554GFDN3555GFDP2922GFDQ2500GFDR2919GFDS2209GFDS2210GFDT2188GFDT2189GFDT2204GFDT2205GFDU2170GFDU2171GFDV2179GFDV2180GFDV2181GFDW2390GFDW2391GFDW2392GFDX2711GFDX2712GFDY1135GFDY1136GFDZ1692GFDZ1693GFEP1181GFEP1182GFEP1183GFEP1184GFER2080GFER2081
- Lot Numbers
- Amount recalled
- 2356 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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