Z-0631-05

BD Exacta 6Fr Percutaneous Sheath Introducer Tray

Name: Z-0631-05 BD Exacta 6Fr Percutaneous Sheath Introducer Tray
Creator: Becton Dickinson Infusion Therapy
Published: 2005-01-10
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2005-01-10 / Terminated / root cause: sterility

FDA source

Becton Dickinson Infusion Therapy began a recall of BD Exacta 6Fr Percutaneous Sheath Introducer Tray on 2005-01-10. The reason FDA records is "Various procedure trays and kits may have an insufficient seal, thus compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0631-05
Status: Terminated
Initiated: 2005-01-10
Posted: 2005-03-18
Terminated: 2005-04-12
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: BD Exacta 6Fr Percutaneous Sheath Introducer Tray.
Product code: DYB Introducer, Catheter
Reason for recall: Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
Root cause tag: sterility
FDA root cause: Other
Action: Customers were contacted by telephone and by letters dated 01/10/05.
Quantity in commerce: 5 units
Distribution: Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
Product codes and lots: Ref. No. 680128, Lot No. 407458

Product code DYB

K941428Class IIExacta Percutaneous Introducer SheathOhmeda Medical / cleared 1994-07-06

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)