Z-2108-2009

Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences...

Name: Z-2108-2009 Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences...
Creator: Integra Life Sciences Corporation
Published: 2009-07-13
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2009-07-13 / Terminated / root cause: packaging

FDA source

Integra Life Sciences Corporation began a recall of Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain... on 2009-07-13. The reason FDA records is "Lack of packaging seal integrity on various pain management kits may compromise sterility of contents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2108-2009
Status: Terminated
Initiated: 2009-07-13
Posted: 2009-09-21
Terminated: 2009-10-23
Recalling firm: Integra Pain Management
Product: Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified by telephone on July 09, 2009 and by "Urgent Medical Device Recall" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.
Product codes and lots: Lot number W0905021

Product code CAZ

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)