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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Sterile Cord Blood Collection Unit, Anticoagulant Citrate Phosphate Dextrose Solution (CPD), Code 791-08 (PALL Medical label) and 791-09V (ViaCord label), UPC code for Pall product code: 791-08: (Case box): (01) 30636207307966 There is no UPC code issued to the ViaCord product. --- The systems are packaged STERILE within a "sterilization pouch" (1 system/pouch) and placed within a foil envelope (1 pouch/ envelope). There are 24 units packaged per case box.
Recall Number B-0699-14
Classification Class II
Code Info Pall Sterile Cord Blood Collection System Code 791-08: Lot number 1356443 (Expiry Date 10/2016); ViaCord's Sterile Cord Blood Collection System, Code 791-09V: Lot numbers 1356441 and 1356442 (Expiry Date 10/2016)
Product Distributed Qty 3 Lots
Reason For Recall Sterile Cord Blood Collection Systems, with a limited number of reports of a blood leaks, were distributed.

Event Detail

Event Id 68308
Product Type Biologics
Status Ongoing
Recalling Firm Pall Corporation
City Port Washington
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern CA, NC, IL, MD, FL, MA