Z-1936-2010

Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change...

Name: Z-1936-2010 Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change...
Creator: Centurion Medical Products
Published: 2010-03-16
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2010-03-16 / Terminated

FDA source

Centurion Medical Products began a recall of Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company... on 2010-03-16. The reason FDA records is "The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1936-2010
Status: Terminated
Initiated: 2010-03-16
Posted: 2010-06-30
Terminated: 2011-02-09
Recalling firm: Centurion Medical Products, LP
Product: Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
Product code: FKG Tray, Start/Stop (Including Contents), Dialysis
Reason for recall: The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.
FDA root cause: Other
Action: The firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.
Quantity in commerce: 3144 kits
Distribution: Nationwide Distribution -- AR and OH.
Product codes and lots: 905058, 902188, 902118, 2008101390, 2008110390, 2008120190, 2009011990, 2009012690, 2009021690, 2009040690, 2009051190, 2009060190, 2009062990, 2009072790, 2009101290, 2009110290 and 2010011890.

Product code FKG

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)