Z-1178-2008

Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged...

Name: Z-1178-2008 Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged...
Creator: Cardinal Health
Published: 2008-02-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-02-12 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health began a recall of Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50... on 2008-02-12. The reason FDA records is "The product has the potential of being non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1178-2008
Status: Terminated
Initiated: 2008-02-12
Posted: 2008-06-11
Terminated: 2008-10-16
Recalling firm: Medtronic, Inc.
Product: Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Cardinal Health, McGaw Park, IL 60085; catalog #SSI-0003
Product code: LRW Scissors, General, Surgical
Reason for recall: The product has the potential of being non-sterile.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cardinal Health notified the accounts who ordered the affected scissors via letter dated 2/12/08, informing them that the scissors that were labeled sterile were subject to a sterility test failure. Upon review of the letter, the accounts were requested to inspect their inventory and immediately segregate any affected product and to telephone Cardinal Customer Sales Operations Group at 1-800-766-0706 for return instructions and to obtain credit/replacement. Any questions were directed to Cardinal's Quality Systems, Professional Services at 800-292-9332.
Quantity in commerce: 16 cases
Distribution: USA Distribution: Kansas and Missouri
Product codes and lots: Catalog SSI-0003, Mfg Date 10/15/07, Order no. 247610

Product code LRW

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)