Rashkind Balloon Septostomy Catheter recall
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The…
Why was Rashkind Balloon Septostomy Catheter recalled?
Subsequent failure of catheters in the field and failed quality testing
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?
Lot Numbers : GFCP2154 GFCR2591 GFCR2592 GFCS2156 GFCU2199 GFCV2587 GFCW1652 GFCW2431 GFCX2712 GFCY2997 GFDN0246 GFDN3553 GFDN3554 GFDN3555 GFDP2922 GFDQ2500 GFDR2919 GFDS2209 GFDS2210 GFDT2188 GFDT2189 GFDT2204 GFDT2205 GFDU2170 GFDU2171 GFDV2179 GFDV2180 GFDV2181 GFDW2390 GFDW2391 GFDW2392 GFDX2711 GFDX2712 GFDY1135 GFDY1136 GFDZ1692 GFDZ1693 GFEP1181 GFEP1182 GFEP1183 GFEP1184 GFER2080 GFER2081
- Product
- Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The…
- Recalling firm
- Medtronic Vascular
- Quantity
- 2356 units
- Distribution
- Worldwide Distribution: USA (nationwide) states of: MA, PA, TN, IN, MI, WA, CA, CO, AZ, NC; and OUS countries of: Algeria, Armenia, Australia, Austria, Barbados, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Macedonia, Malaysia, Martinique, Moldova, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Tunisia, United Arab Emirates, and United Kingdom.
- Recall date
- October 28, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)