Z-1222-06

IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International...

Name: Z-1222-06 IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International...
Creator: International Biophysics Corp
Published: 2005-08-16
License: https://open.fda.gov/license/

International Biophysics Corp. / initiated 2005-08-16 / Terminated / root cause: labeling and UDI

FDA source

International Biophysics Corp began a recall of IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX on 2005-08-16. The reason FDA records is "Tyvek pouches containing device labeled as sterile have defective seals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1222-06
Status: Terminated
Initiated: 2005-08-16
Posted: 2006-07-12
Terminated: 2006-07-17
Recalling firm: International Biophysics Corp.
Product: IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: Tyvek pouches containing device labeled as sterile have defective seals.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm notified customer via telephone on 08/16/05.
Quantity in commerce: 179 units.
Distribution: Product distributed to one hospital located in FL.
Product codes and lots: Lot #042805-100335.

Product code DWE

K841959Class IICardio Metric Custom Perfusion TubingSterile Design, Inc. / cleared 1984-10-19

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)