—#48839

Product

Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K790882, K933316
Affected lot / code info: Product No. AP-06022. Lot Numbers: 12025, 12026, MF2082053, MF2092149, MF2102348, MF2112612, MF2112798, MF2122887, MF3013239, MF3023441, MF3033609, MF3033767, MF3043953, MF3054471, MF3054551, MF3064671, MF3064720, MF3074950, MF3075080, MF3085227, MF3085410, MF3106022, MF3126356, MF3116146, MF4020300, MF4020624, MF4031189, MF4041636, MF4041931, MF4052351, MF4063054, MF4063107, MF4063265, MF4073781, MF4073838, MF4105285, MF4105479, MF4105680, MF4126531, MF4126772, MF4126885, MF5017407, MF5028155, MF5038764, MF5050041, MF5059731, MF5059893, MF5060649, MF5081721, MF5082121, MF5092678. MF5103209, MF5103504, MF5113992, MF5114145, MF5124303, MF6015495, MF6036710, MF6047367, MF6047368, MF6057762, MF6058411, MF6068650, MS3110150, MS4041840.

Why it was recalled

Catheter has separated from the infusion port body.

Root cause (FDA determination)

Other

Action the firm took

The recall notification was sent out to their US customers on 9/29/2006.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: Nationwide. The firm is NOT recalling from international accounts.

Timeline

Recall initiated: 2006-09-29
Posted by FDA: 2006-12-19
Terminated: 2007-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.