FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: Material ECVC215, CVC MULTI-LUMEN INSERTION BUNDLE, CENTURION CVC MULTI-LUMEN INSERTION BUNDLE, REORDER ECVC215, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION
- Recall number
- Z-2361-2011
- Recalling firm
- Centurion Medical Products Corporation
- Product
- Material ECVC215, CVC MULTI-LUMEN INSERTION BUNDLE, CENTURION CVC MULTI-LUMEN INSERTION BUNDLE, REORDER ECVC215, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION
- Status
- Terminated
- Initiated
- 2011-03-31
- Posted
- 2011-05-27
- Terminated
- 2011-09-13
- Reason
- This voluntary sub-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
- Material/Component Contamination
- Action
- 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.
- Quantity
- 15
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- BATCH 2009110550 2009100550, 2009111650, 2009121550, 2010021950, 2010040550, 2010060950 AND 2010062850. .
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRS
- Firm FEI
- 3008403546
- Firm city
- Williamston
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28