Z-1140-2010

Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1...

Name: Z-1140-2010 Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1...
Creator: Centurion Medical Products
Published: 2010-02-01
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2010-02-01 / Terminated / root cause: labeling and UDI

FDA source

Centurion Medical Products began a recall of Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1... on 2010-02-01. The reason FDA records is "A supplier notified this firm of a recall of their Huber needles because the needles that are labeled as non-coring could core 60-72% of the time. Centurion is doing a sub recall of their kits that contain the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1140-2010
Status: Terminated
Initiated: 2010-02-01
Posted: 2010-03-15
Terminated: 2010-11-08
Recalling firm: Centurion Medical Products, LP
Product: Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill kit.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: A supplier notified this firm of a recall of their Huber needles because the needles that are labeled as non-coring could core 60-72% of the time. Centurion is doing a sub recall of their kits that contain the referenced needles.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: An "URGENT MEDICAL DEVICE WITHDRAWAL" notice dated January 26, 2010, was sent to customers via certified mail. The notice described the product, problem and action to be taken by the customers. The customers were instructed: DO NOT USE THESE AFFECTED PRODUCTS. PLEASE RETURN ALL AFFECTED PRODUCTS IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED. The customers were also instructed to report any adverse reactions experienced with the use of the product and/or quality problems to MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078 by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch. The customers were also instructed to check the lot numbers of products in inventory to determine if they have products affected by this withdrawal and complete and return the enclosed Customer Response Form by fax or email. Direct all inquiries to: EXEL International Customer Service 727-827-1922 ext. 0 Monday through Friday 9am-5pm EST or E-mail [email protected]
Quantity in commerce: 880 kits
Distribution: USA only
Product codes and lots: 911127, 901218, 908258, 2008091590, 2008111790, 2009011290, 2009062290, 2009090790, 2009100590 and 2009112390.

Product code FMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)