Recalls / —
—#99204
Product
Material ULT2175, ULTIMATE LINE TRAY, CENTURION ULTIMATE LINE TRAY, REORDER ULT2175, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION
- FDA product code
- LRS — I.V. Start Kit
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected lot / code info
- BATCHES 2010021550, 2010042850, 2010052650, 2010070850 AND 2010081950.
Why it was recalled
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.
Root cause (FDA determination)
Material/Component Contamination
Action the firm took
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.
Recalling firm
- Firm
- Centurion Medical Products Corporation
- Address
- 100 Centurion Way, Williamston, Michigan 48895-9086
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2011-03-31
- Posted by FDA
- 2011-05-27
- Terminated
- 2011-09-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #99204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.