RecallDepth

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015

This recall has been terminated (originally issued December 19, 2006).

Company
Arrow International Inc
Recall Initiated
September 29, 2006
Posted
December 19, 2006
Terminated
June 4, 2007
Recall Number
Z-0284-2007
Quantity
890
Firm Location
Reading, PA
Official Source
View on FDA website ↗

Reason for Recall

Catheter has separated from the infusion port body.

Distribution

Nationwide. The firm is NOT recalling from international accounts.

Lot / Code Info

Product No. AP-06015. Lot Number: 11953, 12024, 12048, MF2122834, MF2122873, MF3013094,MF3023399, MF3033565, MF3033661, MF3043929,MF3044026, MF3044155, MF3054297, MF3054407, MF3064741, MF3074954, MF3085360, MF3106021,MF4016605, MF4020460, MF4031011, MF4031501, MF4041930, MF4062927,MF4063051, MF4073944, MF4094579, MF4094883, MF4095027, MF4116113,MF4126523, MF5017401, MF5049107, MF5049320, MF5059727, MF5060170,MF5060348, MF5060463, MF5081716, MF5082118, MF5082247, MF5113788,MF5113989, MF5124143, MF6014773, MF6025691, MF6036470, MF6036928,MF6047447, MF6057759, MF6058188, MF6068647, MF6079327, MS3110160,MS4073806.

Root Cause

Other

Action Taken

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

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