Recall Z-2299-2011
Centurion Medical Products Corporation · initiated March 31, 2011
Product
Material CVI2590, INSERTION/PPE KIT, CENTURION INSERTION/PPE KIT, Reorder CVI2590, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895 USA 800.248.4058 www.centurionmp.com, LATEX FREE STERILE FACILITATES LINE PLACEMENT
Codes / lots: BATCHES 2009102850, 2009121750, 2010030250, 20061550, 2010072650 AND 2010071650.
Reason for recall
This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates.
FDA-determined cause: Material/Component Contamination
Action taken
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.
Details
- Recall number
- Z-2299-2011
- Initiated
- March 31, 2011
- Posted by FDA
- May 27, 2011
- Terminated
- September 13, 2011
- Product code
- LRS – I.V. Start Kit
- Quantity
- 130
- Distribution
- Nationwide Distribution
- Recalling firm
- Centurion Medical Products Corporation, Williamston, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2296-2011 | Material, CVI2615, PICC INSERTION TRAY PICC Insertion Tray, Reorder CVI2615, CENTURION…This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9%… | 03/31/2011Terminated |
| Z-2297-2011 | Material 301-00, INSERTION TRAY , NeoMedical Incorporated, V-CATH INSERTION TRAY, REF…This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9%… | 03/31/2011Terminated |
| Z-2298-2011 | Material CVI2050, PICC LINE TRAY, CENTURION PICC Line Tray, Reorder CVI2050, STERILE…This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9%… | 03/31/2011Terminated |
| Z-2300-2011 | Material CVI2685, PICC INSERTION TRAY, CENTURION PICC INSERTION TRAY, Reorder CVI2685…This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9%… | 03/31/2011Terminated |
| Z-2301-2011 | Material CVI2690, PICC INSERTION TRAY, CENTURION PICC INSERTION TRAY, REORDER CVI2690…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2302-2011 | Material CVI2795, PICC INSERTION TRAY,CENTURION PICC INSERTION TRAY, REORDER CVI2795…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2303-2011 | Material CVI2880, PICC LINE KIT, CENTURION PICC LINE KIT, REORDER CVI2880, STERILE…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2304-2011 | Material CVI2960, PICC LINE TRAY ,CENTURION PICC LINE TRAY, REORDER CVI2960, STERILE...…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2305-2011 | Material CVI2970, UNIVERSAL INSERTION / PROTECTION KIT, CENTURION UNIVERSAL…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2306-2011 | Material CVI2980, PICC INSERTION TRAY, CENTURION PICC INSERTION TRAY, REORDER CVI2980…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2307-2011 | Material CVI3015, ADULT PICC INSERTION TRAY, MANUFACTURED FOR LEE MEDICAL INC, 2550…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2308-2011 | Material CVI3030, TEMPORARY PACEMAKER INSERTION TRAY, CENTURION TEMPORARY PACEMAKER…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2309-2011 | Material CVI3070, CENTRAL LINE PROCEDURE TRAY, CENTURION CENTRAL LINE PROCEDURE TRAY…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2310-2011 | Material CVI3105, PICC INSERTION KIT, CENTURION PICC INSERTION TRAY, REORDER CVI3105…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2311-2011 | Material CVI3145, CENTRAL LINE INSERTION BUNDLE, CENTURION CENTRAL LINE INSERTION…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2312-2011 | Material CVI3270 PICC INSERTION TRAY, CENTURION PICC INSERTION TRAY, REORDER CVI3270…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2313-2011 | Material CVI3155, PICC INSERTION TRAY, CENTURION PICC INSERTION TRAY, REORDER CVI3155…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2314-2011 | Material CVI3325, PICC LINE INSERTION KIT, CENTURION PICC LINE INSERTION KIT, REORDER…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2315-2011 | Material CVI3435, INTRODUCER BUNDLE, CENTURION INTRODUCER BUNDLE, REORDER CV13435…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2316-2011 | Material CVI680B, CENTRAL CATHETER INSERTION TRAY, CENTURION CENTRAL CATHETER INSERTION…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2317-2011 | Material CVI980, PICC INSERTION TRAY, CENTURION PICC INSERTION TRAY, REORDER CV1980…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2318-2011 | Material DT10010, PICC/MIDLINE INSERTION TRAY, CENTURION PICC/MIDLINE INSERTION TRAY…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2319-2011 | Material DT10510, INSERTION/PROTECTION KIT, CENTURION INSERTION/PROTECTION KIT, SNAG…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2320-2011 | Material DT10595, CENTRAL LINE INSERTION TRAY, CENTURION CENTRAL LINE INSERTION TRAY…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2321-2011 | Material DT10605, INSERTION/PROTECTION KIT, CENTURION INSERTION/PROTECTION KIT, REORDER…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2322-2011 | Material DT11520, CVC ACCESSORY KIT, CENTURION CVC ACCESSORY KIT, REORDER DT11520…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2323-2011 | Material DT11980, VAD TRAY, CENTURION HANNIBAL CLINIC VAD TRAY, REORDER DT11980…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2324-2011 | Material DT11315, CENTRAL LINE ACCESSORY PACK, CENTURION CENTAL LINE ACCESSORY PACK…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2325-2011 | Material DT12050, PORT ACCESS TRAY, CENTURION Port Access Tray, Reorder DT 12050…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |
| Z-2326-2011 | Material DT11375, PICC PROCEDURE TRAY, CENTURION PICC Procedure Tray, Reorder DT11375…This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP… | 03/31/2011Terminated |