Z-0730-2008

Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co...

Name: Z-0730-2008 Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co...
Creator: Tri-State Hospital Supply Corporation
Published: 2007-10-26
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2007-10-26 / Terminated / root cause: labeling and UDI

FDA source

Tri-State Hospital Supply Corporation began a recall of Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI. 48844. The primary kit is labeled as... on 2007-10-26. The reason FDA records is "Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label". 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-0730-2008
Status: Terminated
Initiated: 2007-10-26
Posted: 2008-02-23
Terminated: 2008-03-13
Recalling firm: Centurion Medical Products, LP
Product: Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI. 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size.
Product code: KDC Instrument, Surgical, Disposable
Reason for recall: Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval of the product.
Quantity in commerce: 396 kits.
Distribution: Nationwide Distribution, including states of Massachusetts and Washington.
Product codes and lots: Lot Number: 907097.

Product code KDC

K012736Class IIMonoject Safety NeedleTyco Healthcare / cleared 2001-10-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)