Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Medline Industries, LP
The hazard
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Medline Kit SKU DYNJ910103BModel UDI/DI 10198459346873 (each) 40198459346874 (case)Model Lot Number 25FBR237Model Medline Kit SKU DYNJ910961AModel UDI/DI 10198459213342 (each) 40198459213343 (case)Model Lot Number 25ABM761Model Lot Number 25BBD107Model Lot Number 25FBD534Model Lot Number 25FBL772.UPC 10198459346873UPC 40198459346874UPC 10198459213342UPC 40198459213343Would you have heard about this one?
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