Z-0968-03

Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011

Name: Z-0968-03 Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011
Creator: MedAmicus,Inc
Published: 2003-06-06
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2003-06-06 / Terminated

FDA source

MedAmicus,Inc began a recall of Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 on 2003-06-06. The reason FDA records is "Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0968-03
Status: Terminated
Initiated: 2003-06-06
Posted: 2003-07-02
Terminated: 2004-07-02
Recalling firm: Greatbatch Medical
Product: Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011
Product code: DYB Introducer, Catheter
Reason for recall: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
FDA root cause: Other
Action: The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
Product codes and lots: Lot Number W24540

Product code DYB

K021044Class IIMadettWolfe Tory Medical, Inc. / cleared 2002-09-11

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)