FDA Medical Device Recalls (openFDA)
Centurion Medical Products: Port Blood Draw Tray "for use with power ports", Reorder DT9410C, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit
- Recall number
- Z-1015-2011
- Recalling firm
- Centurion Medical Products
- Product
- Port Blood Draw Tray "for use with power ports", Reorder DT9410C, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit
- Status
- Terminated
- Initiated
- 2010-12-06
- Posted
- 2011-02-01
- Terminated
- 2011-02-16
- Reason
- The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS)".
- Root cause
- Other
- Action
- The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: sdfeedback@covidien.com. Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: sdfeedback@covidien.com or fax: 302-822-6009.
- Quantity
- 140 kits
- Distribution
- Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.
- Lot, serial or model codes
- 2009120880 and 2010012580.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRS
- Firm FEI
- 1824619
- Firm city
- Howell
- 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