Z-0464-2014Class II

Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which...

Name: Z-0464-2014 Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which...
Creator: Centurion Medical Products Corporation
Published: 2013-10-28
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2013-10-28 / Terminated / root cause: labeling and UDI

FDA source

Centurion Medical Products Corporation began a recall of Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION... on 2013-10-28. FDA classified it as Class II and gives the reason as "Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies". 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-0464-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-28
Posted: 2013-12-06
Terminated: 2014-01-29
Recalling firm: Centurion Medical Products, LP
Product: Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure
Product code: LDQ
Reason for recall: Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Centurion sent a Urgent Recall Notification letter via Certified Mail October 31, 2013, return receipt to all affected customers. The affected Centurion Medical Products Corporation sales representatives were notified via email on October 28, 2013. Customers were instructed to destroy all implicated product and complete the accountability record included with the notice and fax to 517-546-3356. Customers were asked to forward a copy of the notice if product was further distributed. Additional notices will be mailed to non-responsive customers via Certified Mail Return Receipt, and will be documented in the recall file. For further questions please call (517) 546-5400.
Quantity in commerce: 500 lots
Distribution: US Distribution including the states of GA, LA and NY.
Product codes and lots: EB84, Lot 2013041801 Expriation 2018/03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06

Product code LDQ

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