Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A475
FDA device recall Z-2447-2012 · posted 2012-09-25 · Terminated
Recall details
- Recalling firm
- Applied Medical Resources Corp
- 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.
- Action taken
- 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 recall60476587@appliedmedical.com 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 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, Is
- Date initiated
- 2012-08-09
- Date posted
- 2012-09-25
- Date terminated
- 2013-03-22
- Location
- Rancho Santa Margarita, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AVD INTIMAX (TM) BILIARY CATHETER (K910006) | Applied Vascular | 1991-02-13 |