Protek Solo Venous Dilator Set: dilator recall
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #…
Why was Protek Solo Venous Dilator Set: dilator recalled?
On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
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/SERIAL: 285586, 00145202, 00145204, 00871587, 00871549, 00871560, 00871561, 00871562, 00871563, 00871564, 00871565, 00871566, 00871567, UDI: (01) 00814112020463(17)231024(11)201024(10)285586 (01)00814112020517(17)220222(11)210118(21)00145202 (01)00814112020517(17)220222(11)210118(21)00145204 (01)00814112020708(17)210203(11)220117(21)00871587 (01)00814112020092(17)210129(11)220117(21)00871549 (01)00814112020092(17)210129(11)220117(21)00871560 (01)00814112020092(17)210129(11)220117(21)00871561 (01)00814112020092(17)210129(11)220117(21)00871562 (01)00814112020092(17)210129(11)220117(21)00871563 (01)00814112020092(17)210129(11)220117(21)00871564 (01)00814112020092(17)210129(11)220117(21)00871565 (01)00814112020092(17)210129(11)220117(21)00871566 (01)00814112020092(17)210129(11)220117(21)00871567
- Product
- Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #…
- Recalling firm
- Cardiac Assist, Inc
- Quantity
- 13 kits
- Distribution
- US Nationwide distribution in the states of AL, AZ, IL, TN.
- Recall date
- May 5, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)