Chameleon PTA Balloon Catheter with Injection Port 5mm recall
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN…
Why was Chameleon PTA Balloon Catheter with Injection Port 5mm recalled?
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
1. 5mm x 40mm x 75cm (CFN CH05-40-75US): UDI-DI: 10884521812260; Lot Numbers: 22201047, 22201424, 22201425, 22202802, 22203008, 22203009, 22203040, 22300536, 22300970, 22300971, 22301116, 22301270, 22400129, 22400572, 22400573, Added 12/13/2024: 22202643, 22300000, 22300969, 22301117. Expansion 12/05/2024 with additional serial numbers: 22202643, 22300000, 22300969, 22301117. 2. 6mm x 40mm x 75cm (CFN CH06-40-75US): UDI-DI: 10884521812277; Lot Numbers: 22201337, 22201908, 22202412, 22202413, 22202611, 22202612, 22202801, 22300151, 22300318, 22300319, 22300320, 22300862, 22300965, 22301285, 22301494, 22301661, 22301895, 22301896, 22302180, 22400243, 22400244, 22400574, 22400576. 3. 7mm x 40mm x 75cm (CFN CH07-40-75US): UDI-DI: 10884521812284; Lot Numbers: 22200635, 22201897, 22202223, 22202426, 22202427, 22202800, 22203055, 22300321, 22300864, 22301028, 22301648, 22301649, 22301889, 22301890, 22302033, 22302034. 4. 8mm x 40mm x 75cm (CFN CH08-40-75US): UDI-DI: 10884521812291; Lot Numbers: 22201015, 22201046, 22201087, 22201785, 22201786, 22201813, 22202144, 22202145, 22202644, 22202645, 22300165, 22300230, 22300534, 22300535, 22300876, 22300877, 22300966, 22301133, 22301134, 22301299, 22301495, 22302032, 22400154, 22400164, 22400165. 5. 9mm x 40mm x 75cm (CFN CH09-40-75US): UDI-DI: 10884521812307; Lot Numbers: 22201364, 22202428, 22203026, 22300152, 22300539, 22301123, 22301124, 22400698, 22400699, 22400858. 6. 10mm x 40mm x 75cm (CFN CH10-40-75US): UDI-DI: 10884521812314; Lot Numbers: 22201814, 22201871, 22202646, 22300185, 22300219, 22300231, 22300863, 22301300, 22301301, 22302026, 22302031, 22302044, 22400153, 22400247, Added 12/13/2024: 22200739, 22201815, 22202176, 22202177, 22202799. Expansion 12/05/2024 with additional serial numbers: 22200739, 22201815, 22202176, 22202177, 22202799. 7. 12mm x 40mm x 75cm (CFN CH12-40-75US): UDI-DI: 10884521812321; Lot Numbers: 22201391, 22201872, 22202781, 22300301, 22300302, 22300878, 22300967, 22300968, 22301269, 22400128, 22400279, Added 12/13/2024: 22202212, 22202213, 22203025, 22300300. Expansion 12/05/2024 with additional serial numbers: 22202212, 22202213, 22203025, 22300300.
- Product
- Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN…
- Recalling firm
- Covidien LP
- Quantity
- 16,336 units
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain and Turkey.
- Recall date
- November 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)