Z-2447-2012Class II

Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM...

Name: Z-2447-2012 Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM...
Creator: Applied Medical Resources Corp
Published: 2012-08-09
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2012-08-09 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER... on 2012-08-09. FDA classified it as Class II and gives the reason as "Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product". 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-2447-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-09-25
Terminated: 2013-03-22
Recalling firm: Applied Medical Resources Corp
Product: Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to complete the attached Recall Notification Confirmation Form and to return it to the firm via e-mail to [email protected] or fax to (949) 713-8832. For product return questions, customers were instructed to contact Sales Operations Administrator at (949) 713-8652.For questions regarding this recall contact the firm at (949) 713-8041.
Quantity in commerce: 40,238 units for all products in Recall Event
Distribution: Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
Product codes and lots: Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2447-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2446-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25
Z-2447-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25
Z-2448-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25

Product code FGE

K910006Class IIAvd Intimax (Tm) Biliary CatheterApplied Vascular / cleared 1991-02-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)