Rashkind Balloon Septostomy Catheter recall
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon…
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 : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFDU2169 GFDV2178 GFDW2400 GFDX2710 GFDY1133 GFDY1134
- Product
- Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon…
- Recalling firm
- Medtronic Vascular
- Quantity
- 505 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)