Z-0061-2007

Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL...

Name: Z-0061-2007 Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL...
Creator: Cardinal Health
Published: 2006-09-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-09-27 / Terminated

FDA source

Cardinal Health began a recall of Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; catalog #9158N on 2006-09-27. The reason FDA records is "The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0061-2007
Status: Terminated
Initiated: 2006-09-27
Posted: 2006-10-21
Terminated: 2008-05-09
Recalling firm: Medtronic, Inc.
Product: Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; catalog #9158N
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
FDA root cause: Other
Action: Cardinal Health sent separate recall letters dated 9/27/06 via UPS next day delivery to those accounts who ordered the drapes alone and those accounts who ordered custom sterile packs and PBDS modules, informing them that the cardiovascular split drapes may tear and/or fray at the reinforced fenestrated trough area during use. The letters listed the catalog numbers and affected lot numbers of the sterile drapes, and the letters sent to the pack and module customers were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to inspect their inventory to determine if they had any of the affected product on hand; segregate the affected inventories; complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of drapes in inventory being destroyed; and contact the El Paso Customer Service Center at 915-779-3681 to order replacement product. Distributors were requested to notify their customers of the recall. An additional letter dated 10/25/06 was sent via UPS overnight delivery to 49 of the accounts, expanding the recall to include lot 06HRD110 of catalog #9158, Convertors Tiburon Cardiovascular Split Drape II, Sterile. The instructions remained the same as those in the 9/27/06 letter.
Quantity in commerce: 1982 units
Distribution: Worldwide Distribution- USA and countries of Kuwait and Australia
Product codes and lots: catalog #9158, lot numbers 17362D; 17361D; 17461D; 17761D; 17762D; 17861D; 17961D; 18061D; 18861D; 19362D; 19461D; 19462D; 19561D; 19862D; 19961D; 21262D; 22861D; 22862D; 22961D; 23361D; 23562D; 23761D.

Product code KKX

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)