TEI Biosciences, Inc.: SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16

Hazard

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Details from the source

Reason for recall: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Distribution: Domestic: Nationwide Distribution. Quantity: 14,535 units Lot/code info: Item No. (UDI-DI): 606-001-002 (10381780112617), 606-001-004 (10381780112624), 606-001-005 (10381780112631), 606-001-006 (10381780112648), 606-001-007 (10381780112655), 606-001-008 (10381780112662), 606-001-009 (10381780112679), 606-001-010 (10381780112686), 606-001-012 (10381780112693), 606-001-013 (10381780112709), 606-001-014 (10381780112716), 606-001-015 (10381780112723), 606-001-016 (10381780112730), 606-001-017 (10381780112747), 606-001-018 (10381780112754), 606-002-002 (10381780112761), 606-002-003 (10381780112778), 606-002-005 (10381780112785), 606-003-001 (10381780112792), 606-003-002 (10381780112808), 606-003-003 (10381780112815).

UPC codes

10381780112617, 10381780112624, 10381780112631, 10381780112648, 10381780112655, 10381780112662, 10381780112679, 10381780112686, 10381780112693, 10381780112709, 10381780112716, 10381780112723, 10381780112730, 10381780112747, 10381780112754, 10381780112761, 10381780112778, 10381780112785, 10381780112792, 10381780112808, 10381780112815

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.