EPA (Environmental Protection Agency)
1 records
epa_echo
1 records
fda
15 records
FDA Recall: TEI Biosciences, Inc. — Class II
20230712
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Product: PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm...
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FDA Recall: TEI Biosciences, Inc. — Class II
20230712
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | Product: SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction...
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FDA Device Recall: PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x2
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; S
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 c
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm,
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm,
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x
2023-07-12
Class II — Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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FDA Device Recall: PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis
2018-01-24
Class II — During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 I...
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