Recall Z-2448-2012— Applied Medical Resources Corp

Name: FDA recall Z-2448-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-09

Class II · Terminated

Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2012-08-09, terminated 2013-03-22. It names one FDA 510(k) clearance: K902256. Product: Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.. Reason: 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..

Recalling firm: Applied Medical Resources Corp
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Terminated: 2013-03-22
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K902256 — IRRIGATION CATHETER 4, 6 AND 10 FRENCHApplied Vascular Devices, Inc.·cleared 1991-02-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.