Z-1841-2008

HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9128...

Name: Z-1841-2008 HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9128...
Creator: Atrium Medical Corporation
Published: 2008-05-12
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2008-05-12 / Terminated / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9128, Size (Fr) 28, # Eyelets 5, 10 per case on 2008-05-12. The reason FDA records is "Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate". 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-1841-2008
Status: Terminated
Initiated: 2008-05-12
Posted: 2008-08-14
Terminated: 2009-08-20
Recalling firm: Atrium Medical Corporation
Product: HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9128, Size (Fr) 28, # Eyelets 5, 10 per case
Product code: GBS Catheter, Ventricular, General & Plastic Surgery
Reason for recall: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice.
Quantity in commerce: 132 cases (10 individual/case)
Distribution: Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
Product codes and lots: Lot #s 10300923, 10311229, 10318744, 10336321, 10348453

Product code GBS

K912645Class IAtriums Pdr Thoracic CatheterAtrium Medical Corp. / cleared 1991-09-13

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)