Recall Z-0707-2012
Codman & Shurtleff, Inc. · initiated October 25, 2011
Product
Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.
Codes / lots: Lot codes: 091D1357 09AD4024 09DD3119 09FD2303 09GD1485 09HD0439 09JD0410 09JD3907 09KD2828 09LD2187 10AD2613 l0BD2115 10CD3938 10FD0538 10GD0534 10ID1319 10lD5075 10JD2337 l0JD3344 10JD4027 l0KD0816 10LD1062 10LD3169 11BD0122 11BD3275 11FD0392 l1FD0648 11GD3385 11HD1641
Reason for recall
Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
FDA-determined cause: Labeling Change Control
Action taken
Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.
Details
- Recall number
- Z-0707-2012
- Initiated
- October 25, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- May 29, 2015
- Product code
- GWM – Device, Monitoring, Intracranial Pressure
- Quantity
- 13845 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0706-2012 | Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-0708-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-0709-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-0710-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |